Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Meclizine HCl 25 mg
OTC - PURPOSE SECTION
Purpose Antiemetic
4483-333 - MOTION TIME
- Set ID
- 7f3ce1e6-c0d6-4b56-8f7a-6368eb46901f
- Manufacturer
- Time-Cap Labs, Inc
- Effective date
- 2018-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 22:57:44
Key Label Information
Uses
INDICATIONS & USAGE SECTION
Uses prevents and treats nausea, vomiting, or dizziness associated with motion sickness
Warnings
WARNINGS SECTION
Warnings Do not give to children under 12 years of age unless directed by a doctor
OTC - DO NOT USE SECTION
Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Directions dosage should be taken one hour before travel starts adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor
Other Label Information
STORAGE AND HANDLING SECTION
Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) in a dry place use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous lactose, colloidal silicon dioxide, crospovidone, dextrose, FD-C red 40 aluminum lake, magnesium stearate, microcrystalline cellulose, modified corn starch, propylene glycol, raspberry flavor, silicon dioxide, sodium saccharin, stearic acid, talc, vanilla flavor
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Meclizine HCL Chewable Tablets
Products
- Motion-Time Chewable
- Meclizine HCl
- MECLIZINE
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| CROSPOVIDONE | 68401960MK | IACT |
| DEXTROSE | IY9XDZ35W2 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) | 461P5CJN6T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| RASPBERRY | 4N14V5R27W | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| VANILLA | Q74T35078H | IACT |
| MECLIZINE HYDROCHLORIDE | HDP7W44CIO | ACTIB |
Complete SPL Sections
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Meclizine HCl 25 mg
OTC - PURPOSE SECTION
Purpose Antiemetic
INDICATIONS & USAGE SECTION
Uses prevents and treats nausea, vomiting, or dizziness associated with motion sickness
WARNINGS SECTION
Warnings Do not give to children under 12 years of age unless directed by a doctor
OTC - ASK DOCTOR SECTION
Do not take unless directed by a doctor if you have trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis
OTC - DO NOT USE SECTION
Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor
OTC - WHEN USING SECTION
When using this product do not exceed recommended dosage drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers 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 health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions dosage should be taken one hour before travel starts adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor
STORAGE AND HANDLING SECTION
Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) in a dry place use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous lactose, colloidal silicon dioxide, crospovidone, dextrose, FD-C red 40 aluminum lake, magnesium stearate, microcrystalline cellulose, modified corn starch, propylene glycol, raspberry flavor, silicon dioxide, sodium saccharin, stearic acid, talc, vanilla flavor
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Meclizine HCL Chewable Tablets
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/7f3ce1e6-c0d6-4b56-8f7a-6368eb46901f/7d3bf3b4-998d-e1df-e053-2991aa0a471c.xml
- XML SHA-256
- 9640cd5f3e50824bc6a4365d533a63021f61e60f1736ff443a3b9c780845cb69
- XML bytes
- 31453
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 333R.jpg | 2018-12-18 |
| otc | 7d3bf3b4-998d-e1df-e053-2991aa0a471c.xml | 2018-12-18 |