Label: DRAMAMINE- dimenhydrinate tablet, chewable
- NDC Code(s): 66715-9809-1
- Packager: Lil' Drug Store Products, Inc.
- 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.
Drug Label Information
Updated December 6, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Use
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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
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Directions
- to prevent motion sickness, the first dose should be taken 1/2 to 1 hour before starting activity
- to prevent or treat motion sickness, see below:
adults and children 12 years and over - take 1 to 2 chewable tablets every 4-6 hours
- do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years - give ½ to 1 chewable tablet every 6-8 hours
- do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years - give ½ chewable tablet every 6-8 hours
- do not give more than 1-½ chewable tablets in 24 hours, or as directed by a doctor
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mg Tablet Pouch Carton
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INGREDIENTS AND APPEARANCE
DRAMAMINE
dimenhydrinate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9809 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ALUMINUM OXIDE (UNII: LMI26O6933) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) STARCH, CORN (UNII: O8232NY3SJ) SORBITOL (UNII: 506T60A25R) Product Characteristics Color orange Score 2 pieces Shape ROUND Size 12mm Flavor ORANGE Imprint Code DRA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9809-1 1 in 1 CARTON 08/26/2016 1 2 in 1 POUCH; 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 05/10/2010 Labeler - Lil' Drug Store Products, Inc. (093103646)