Label: DRAMAMINE- dimenhydrinate tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 52904-962-04, 52904-962-25 - Packager: Select Corporation
- This is a repackaged label.
- Source NDC Code(s): 63029-901
- 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 April 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Use
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Warnings
Do not give to children under 2 years of age unless directed by a doctor
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 1/2 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 1/2 chewable tablet every 6-8 hours
- do not give more than 1½ chewable tablets in 24 hours, or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mg Tablet Packet Carton
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INGREDIENTS AND APPEARANCE
DRAMAMINE
dimenhydrinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-962(NDC:63029-901) 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 silicon dioxide (UNII: ETJ7Z6XBU4) croscarmellose sodium (UNII: M28OL1HH48) lactose, unspecified form (UNII: J2B2A4N98G) magnesium stearate (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color ORANGE Score 2 pieces Shape ROUND Size 8mm Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52904-962-04 1 in 1 BLISTER PACK 01/15/2012 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:52904-962-25 25 in 1 CARTON 01/15/2012 2 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 01/15/2012 Labeler - Select Corporation (053805599)
