Indications and uses
for prevention and treatment of nausea, vomiting or dizziness associated with motion sickness
Dimenhydrinate
- Manufacturer
- Acme United Corporation
- Effective date
- 2020-11-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:33:49
Label at a glance#
ProductDimenhydrinate
Active ingredientDIMENHYDRINATE
Label structure10 sections
Dosage and administration
To prevemt motion sickness the first dose should be taken ½ to 1 hour before starting activity. To prevent or treat motion sickness: Adults and Children (12 years and older) take 1-2 tablets every 4-6 hours, not more than 8 tablets in 24 hours, or as directed by doctor. Children 6 to under 12 years give 1 tablet every 6-8 hours, not more than 3 tablets in 24 hours or as directed by doctor. Children 2 to under 6 ye...
Contacts and useful links#
Websitewww.firstaidonly.com
www.FirstAidOnly.com
www.FirstAidOnly.comLabel contents#
Full prescribing information#
Drug Facts
Active Ingredient (in each tablet)
Dimenhydrinate 50 mg
OTC - PURPOSE SECTION
Purpose
Antiemetic
Uses
for prevention and treatment of nausea, vomiting or dizziness associated with motion sickness
WARNINGS SECTION
OTC - DO NOT USE SECTION
Do not use in children under 2 years of age unless directed by a doctor
OTC - ASK DOCTOR SECTION
Ask doctor before use if you have
- breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers.
OTC - WHEN USING SECTION
When using this product
- marked drowsiness may occir
- avoid alcoholic drinks
- alcohol, sedatives and traquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding, ask a helath professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
In case of overdose, get medical help or contact Poison Control Center (800-222-1222) right away.
Directions
To prevemt motion sickness the first dose should be taken ½ to 1 hour before starting activity.
To prevent or treat motion sickness:
| Adults and Children (12 years and older) | take 1-2 tablets every 4-6 hours, not more than 8 tablets in 24 hours, or as directed by doctor. |
| Children 6 to under 12 years | give 1 tablet every 6-8 hours, not more than 3 tablets in 24 hours or as directed by doctor. |
| Children 2 to under 6 years | give ¼ to ½ tablet every 6-8 hours, not more than 1½ tablets in 24 hours or as directed by a doctor |
Other information
- each tablet contains calcium 29 mg
- store at room temperature
- do not use if packet is open or torn
INACTIVE INGREDIENT SECTION
croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose
Questions?
1-800-835-2263
SPL UNCLASSIFIED SECTION
Retain carton for complete product information
Manufactured for:
Acme United Corporation
55 Walls Dr, Fairfield, CT 06824
Made in the USA
©2018 Acme United Corporation
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Physician Care®
Motion Sickness
Dimenhydrinate/ Antiemetic
Nausea, Vomiting and Dizziness Relief
Tamper-Evident Packets of 2 Tablets
Do not use if packet is open or torn.
Dimenhydrinate 50mg
100 Tablets (50 Packets, 2 Tablets each)
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0924-1007-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-b430-0266-e053-dadaa90a7c1a | 1006-Acme |
| 0924-1007-02 | 2023-01-30 | C162847 | 48780-1 | f386c649-b430-0266-e053-dadaa90a7c1a | 1006-Acme |
| 0924-1007-03 | 2023-01-30 | C162847 | 48780-1 | f386c649-b430-0266-e053-dadaa90a7c1a | 1006-Acme |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0924-1007-01 | Dimenhydrinate | 50 in 1 CARTON | TABLET | 50 | 2 | |
| 0924-1007-01 | Dimenhydrinate | 2 in 1 PACKET | TABLET | 2 | 2 | |
| 0924-1007-02 | Dimenhydrinate | 6 in 1 BAG | TABLET | 6 | 2 | |
| 0924-1007-02 | Dimenhydrinate | 2 in 1 PACKET | TABLET | 2 | 2 | |
| 0924-1007-03 | Dimenhydrinate | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Dimenhydrinate
- CROSCARMELLOSE SODIUM
- CROSCARMELLOSE
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- CHLORTHEOPHYLLINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0924-1007 | 0924-1007-02, 0924-1007-01, 0924-1007-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | O7TSZ97GEP | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| DIMENHYDRINATE | JB937PER5C | ACTIB |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| b44fec56-48e0-1d87-e053-2a95a90a10c8 | 7b32c52a-f2b0-4acc-e053-2a91aa0a5bcc | 2020-11-17 | Warnings | b44fec56-48e0-1d87-e053-2a95a90a10c8 7b32c52a-f2b0-4acc-e053-2a91aa0a5bcc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.