For Consumers (the general public): Naus-Ease® (Meclizine Hydrochloride), USP Tablets are used for the prevention and treatment of nausea and vomiting, or dizziness associated with motion sickness. For Health Professionals: Based on a review of Meclizine Hydrochloride, USP drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications of Meclizine ...
Adults and children 12 years of age and over: Take 1 to 2 Naus-Ease® (Meclizine Hydrochloride), USP Tablets (25 mg to 50 mg) by mouth once daily, or as directed by a physician. The initial dose of 25 mg to 50 mg of Naus-Ease® (Meclizine Hydrochloride), USP Tablets should be taken one hour prior to travel for the prevention and treatment of motion sickness. Thereafter, the dose may be repeated every 24 hours for th...
www.nausease.comMeclizine Hydrochloride, USP 25 mg
Antiemetic
Chemically, Meclizine Hydrochloride, USP is 1-( p-Chloro-α-phenylbenzyl)-4-( m-methylbenzyl) piperazine dihydrochloride monohydrate. Meclizine Hydrochloride, USP is an oral antiemetic, which is a white to slightly yellowish crystalline powder having a slight odor and is tasteless. The molecular weight is 481.89 g/mol. It has the following structural formula:
C 25H 27CIN 2·2HCl·H 20 M.W. 481.88544 g/mol
Meclizine Hydrochloride, USP is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.
The available pharmacokinetic information for Meclizine Hydrochloride, USP following oral administration has been summarized from published literature.
Meclizine Hydrochloride, USP is absorbed after oral administration with maximum plasma concentrations reaching at a median T max value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form.
Drug distribution characteristics for Meclizine Hydrochloride, USP in humans remains unknown.
The metabolic fate of Meclizine Hydrochloride, USP in humans is unknown. In an in vitro metabolic study using human hepatic microsome and recombinant CYP enzyme, CYP 2D6 was found to be the dominant enzyme for metabolism of Meclizine Hydrochloride, USP.
The genetic polymorphism of CYP2D6 that results in extensive-, poor-, intermediate- and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in Meclizine Hydrochloride, USP exposure.
Meclizine Hydrochloride, USP has a plasma elimination half-life of about 5-6 hours in humans.
For Consumers (the general public):
Naus-Ease® (Meclizine Hydrochloride), USP Tablets are used for the prevention and treatment of nausea and vomiting, or dizziness associated with motion sickness.
For Health Professionals:
Based on a review of Meclizine Hydrochloride, USP drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications of Meclizine Hydrochloride, USP as follows:
1. The prevention and treatment (management) of nausea and vomiting, and dizziness associated with motion sickness.
2. For the treatment of vertigo.
Meclizine Hydrochloride, USP is contraindicated in individuals who have shown a previous hypersensitivity to it.
Clinical studies establishing safety and effectiveness in children under 12 years of age have not been done; therefore, usage is not recommended in children under 12 years of age unless directed by a doctor.
Due to its potential anticholinergic action, do not take unless directed by a doctor if you have a breathing problem such as asthma, emphysema, or chronic bronchitis, glaucoma, or difficulty in urination due to enlargement of the prostate gland.
Ask a doctor before use if you are taking sedatives or tranquilizers.
When using this product:
1. Do not exceed the recommended dosage.
2. May cause drowsiness.
3. Patients should avoid alcoholic beverages while taking this drug.
4. Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Therefore patients are reminded caution when driving or operating machinery.
5. Alcohol, sedatives and tranquilizers may increase drowsiness.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center right away.
Call Poison Control at 1-800-222-1222
Clinical studies establishing safety and effectiveness in children under 12 years of age have not been done; therefore, usage is not recommended in children under 12 years of age unless directed by a doctor.
Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25 to 50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that Meclizine Hydrochloride, USP increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, Meclizine Hydrochloride, USP or any other medication, should be used during pregnancy only if clearly necessary, and after speaking with a health professional.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Meclizine Hydrochloride, USP is administered to a nursing woman.
The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. As Meclizine Hydrochloride, USP undergoes metabolism, hepatic impairment may result in increased systemic exposure of the drug. Treatment with Meclizine Hydrochloride, USP should be administered with caution in patients with hepatic impairment.
The effect of renal impairment on the pharmacokinetics of Meclizine Hydrochloride, USP has not been evaluated. Due to a potential for drug/metabolite accumulation, Meclizine Hydrochloride, USP should be administered with caution in patients with renal impairment and in the elderly as renal function generally declines with age.
There may be increased CNS depression when Meclizine Hydrochloride, USP is administered concurrently with other CNS depressants, including alcohol, tranquilizers and sedatives. (see WARNINGS)
Based on in vitro evaluation, Meclizine Hydrochloride, USP is metabolized by CYP2D6. Therefore there is a possibility for a drug interaction between Meclizine Hydrochloride, USP and CYP2D6 inhibitors.
Keep out of reach of children. In case of an overdose, seek medical help or contact a Poison Control Center immediately.
Call Poison Control at 1-800-222-1222.
Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.
Adults and children 12 years of age and over: Take 1 to 2 Naus-Ease® (Meclizine Hydrochloride), USP Tablets (25 mg to 50 mg) by mouth once daily, or as directed by a physician.
The initial dose of 25 mg to 50 mg of Naus-Ease® (Meclizine Hydrochloride), USP Tablets should be taken one hour prior to travel for the prevention and treatment of motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.
Each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, D&C Yellow #10, Aluminum Lake (15-20%).
Store at controlled room temperature 20-25°C (68-77°F).
Protect from heat and humidity.
Use by expiration date on package.
Naus-Ease® (Meclizine Hydrochloride), USP Tablets are available in 25mg strengths, and is available in 8 and 16 count package sizes.
25 mg tablets; Yellow; Oval shaped; Scored; "TL121" imprinted on each tablet
Naus-Ease® (Meclizine Hydrochloride), USP; 8 Tablets: NDC 49467-124-08
Naus-Ease® (Meclizine Hydrochloride), USP; 16 Tablets: NDC 49467-124-16
Distributed by:
Sunascen Therapeutics LLC
Rockville, MD 20850 USA
Sunascen Therapeutics LLC
PO Box 2773
Wilmington DE 19805
More information is available on the web at www.nausease.com
Naus-Ease® (Meclizine Hydrochloride), USP; Tablets 25 mg Each
Antiemetic – Prevent and Treat: Nausea and Vomiting
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
| Class | Version | Type | Effective |
|---|---|---|---|
| MECLIZINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ac6963c4-31c6-325f-ee58-83a0a06597ad | Product name | 5 | 20221206 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49467-124-08 | 2024-07-30 | C162847 | 48780-1 | f386c64a-3821-0266-e053-dadaa90a7c1a | NAUS-EASE® (Meclizine Hydrochloride), USP; Tablet - Product Information |
| 49467-124-16 | 2024-07-30 | C162847 | 48780-1 | f386c64a-3821-0266-e053-dadaa90a7c1a | NAUS-EASE® (Meclizine Hydrochloride), USP; Tablet - Product Information |
| 49467-124-08 | 2024-01-30 | C162847 | 48780-1 | f386c64a-3821-0266-e053-dadaa90a7c1a | NAUS-EASE® (Meclizine Hydrochloride), USP; Tablet - Product Information |
| 49467-124-16 | 2024-01-30 | C162847 | 48780-1 | f386c64a-3821-0266-e053-dadaa90a7c1a | NAUS-EASE® (Meclizine Hydrochloride), USP; Tablet - Product Information |
| 49467-124-08 | 2023-01-31 | C162847 | 48780-1 | f386c64a-3821-0266-e053-dadaa90a7c1a | NAUS-EASE® (Meclizine Hydrochloride), USP; Tablet - Product Information |
| 49467-124-16 | 2023-01-31 | C162847 | 48780-1 | f386c64a-3821-0266-e053-dadaa90a7c1a | NAUS-EASE® (Meclizine Hydrochloride), USP; Tablet - Product Information |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49467-124-08 | NAUS-EASE | 1 in 1 CARTON | TABLET | 1 | 7 | |
| 49467-124-08 | NAUS-EASE | 8 in 1 BLISTER PACK | TABLET | 8 | 7 | |
| 49467-124-16 | NAUS-EASE | 2 in 1 CARTON | TABLET | 2 | 7 | |
| 49467-124-16 | NAUS-EASE | 8 in 1 BLISTER PACK | TABLET | 8 | 7 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MECLIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | HDP7W44CIO | 3 | |
| MECLIZINE | ACTIVE MOIETY | 3L5TQ84570 | 3 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49467-124 | 49467-124-08, 49467-124-16 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| ALUMINUM OXIDE | LMI26O6933 | IACT |
| MECLIZINE HYDROCHLORIDE | HDP7W44CIO | ACTIB |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, DELAYED RELEASE / ORAL | 2087 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, DELAYED RELEASE / ORAL | 2313 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, EXTENDED RELEASE / ORAL | 53 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, CHEWABLE / ORAL | 216 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUPPOSITORY / RECTAL | 0.11 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 64 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 690 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, DELAYED RELEASE / ORAL | 1.9 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / INTRAMUSCULAR | 150 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | INJECTION / INTRAMUSCULAR | 1 %w/v | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / BUCCAL | 43 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 107 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | PELLET / ORAL | 640 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, COATED / ORAL | 1301 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / SUBLINGUAL | 0.23 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, LIQUID FILLED / ORAL | 1.51 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER, FOR SUSPENSION / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GEL / DENTAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / SUBCUTANEOUS | 98 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040659-001 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | |
| A040659-002 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 |
| Application-product | TE code |
|---|---|
| A040659-001 | AA |
| A040659-002 | AA |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040659-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | 2010-06-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040659-002 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-06-04 | 4b0b4de00fa7… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A040659-001 | AA | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A040659-002 | AA | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A040659-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040659-002 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A040659-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040659-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040659-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040659-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040659-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040659-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040659-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040659-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040659-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040659-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040659-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040659-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040659-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040659-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040659-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040659-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040659-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040659-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040659-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040659-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040659-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040659-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040659-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040659-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040659-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040659-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040659-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040659-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040659-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040659-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040659-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040659-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040659-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040659-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040659-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040659-002 | AA | 1 | 4b0b4de00fa7… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f397aa41-4084-de07-e053-2a95a90a862a | 43f50d2f-6c27-4b33-b4a8-44e810f93e6f | 2023-01-31 | Warnings, Adverse reactions | f397aa41-4084-de07-e053-2a95a90a862a 43f50d2f-6c27-4b33-b4a8-44e810f93e6f |
Adverse event summaries are temporarily unavailable. Other product information remains available.