Label: DRAMAMINE FOR KIDS- dimenhydrinate tablet, chewable
- NDC Code(s): 63029-910-01
- Packager: Medtech Products Inc.
- 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 April 9, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
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Warnings
Ask a doctor before use if the child has
- A breathing problem such as emphysema or chronic bronchitis
- Glaucoma
- A breathing problem such as emphysema or chronic bronchitis
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Directions
- To prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
- To prevent or treat motion sickness see below:
Children 2 to under 6 years
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Give ½ to 1 chewable tablet every 6-8 hours
- Do not five more than 3 chewable tablets in 24 hours or as directed by a doctor
Children 6 to 12 years
- Give 1 to 2 chewable talets every 6-8 hours
- Do not give more than 6 chewable tablets in 24 hours, or as directed by a doctor
- To prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
- Other information
- Inactive ingredients
- Questions?
- Principal display panel
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INGREDIENTS AND APPEARANCE
DRAMAMINE FOR KIDS
dimenhydrinate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-910 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE 25 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GRAPE (UNII: 6X543N684K) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) SORBITOL (UNII: 506T60A25R) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor GRAPE Imprint Code DRA Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-910-01 1 in 1 CASE 02/15/2012 1 8 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 02/15/2012 Labeler - Medtech Products Inc. (122715688)