Label: DIMENHYDRINATE tablet, film coated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated March 27, 2013
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
To prevent motion sickness, the first dose should be taken one-half to one hour before starting activity.
Adults and children 12 years of age and over - 1 to 2 tablets every 4 to 6 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age 1/2 to 1 tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
Children 2 to under 6 years of age - 1/4 to 1/2 tablet every 6 to 8 hours,not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor
- INDICATIONS & USAGE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
dimenhydrinate tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-352 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) Product Characteristics Color white Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code TCL;352 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-352-36 36 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 01/28/2011 Labeler - Time Cap Labs, Inc (037052099) Establishment Name Address ID/FEI Business Operations Time Cap Labs, Inc. 037052099 manufacture(49483-352)