Label: DIMENHYDRINATE tablet
- NDC Code(s): 0904-6772-12
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated November 13, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- Uses
-
WARNINGS
Do not give to children under 2 years of age unless directed by a doctor
Ask a doctor before use if you have
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
-
Directions
■ to prevent motion sickness, the rst 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 4-6 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 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor
■ children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor
- Other information
- INACTIVE INGREDIENT
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DIMENHYDRINATE
dimenhydrinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6772 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (CHLORTHEOPHYLLINE - UNII:GE2UA340FM) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code 1006;1006 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-6772-12 1 in 1 CARTON 02/14/2019 1 12 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 02/14/2019 Labeler - Major Pharmaceuticals (191427277)