NDC | 63029-905-10 |
Set ID | 7fec7791-c242-4e43-8184-32820e657afb |
Category | HUMAN OTC DRUG LABEL |
Packager | Medtech Products Inc. |
Generic Name | |
Product Class | Antiemetic |
Product Number | |
Application Number | PART336 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Use
for prevention and treatment of these symptoms associated with motion sickness:
■nausea ■vomiting ■dizziness
Close - Warnings
Ask a doctor before use if you have
■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma
■ trouble urinating due to an enlarged prostate gland
When using this product
■ drowsiness may occur
■ avoid alcoholic drinks
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- Directions
■ take first dose one hour before activity that may result in nausea
■ adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
Close - Other information
- Inactive ingredients
anhydrous lactose, corn starch, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose
Close - Questions?
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
DRAMAMINE - N
meclizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-905 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color YELLOW Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-905-10 2 in 1 BOX 01/15/2018 1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part336 01/15/2018 Labeler - Medtech Products Inc. (122715688)