Label: DIMENHYDRINATE tablet
- NDC Code(s): 0924-1007-01, 0924-1007-02, 0924-1007-03
- Packager: Acme United Corporation
- 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 November 17, 2020
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- Drug Facts
Ask doctor before use if you have
- breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland.
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
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
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-1007 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:0924-1007-02 6 in 1 BAG 04/18/2019 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0924-1007-01 50 in 1 CARTON 04/18/2019 2 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:0924-1007-03 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 04/18/2019 Labeler - Acme United Corporation (001180207)