Label: DIMENHYDRINATE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68151-1712-2 - Packager: Carilion Materials Management
- This is a repackaged label.
- Source NDC Code(s): 0603-3327
- 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 21, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- INDICATIONS & USAGE
- Warnings
- DO NOT USE
- Ask a doctor before use if you have
- ASK DOCTOR/PHARMACIST
- When using this product
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
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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, use the following dosing
adults and children 12 years and over
1-2 tablets every 4-6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
children 6 years to under 12 years
1/2-1 tablet every 6-8 hours; not more than 3 tablets in 24 hours, or as directed by a doctor
children 2 years to under 6 years
1/4-1/2 tablet every 6-8 hours; not more than 1 1/2 tablets in 24 hours, or as directed by a doctor
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Dimenhydrinate
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INGREDIENTS AND APPEARANCE
DIMENHYDRINATE
dimenhydrinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68151-1712(NDC:0603-3327) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE 50 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code 0111;V Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68151-1712-2 1 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part336 03/01/2004 Labeler - Carilion Materials Management (079239644) Registrant - Carilion Materials Management (079239644) Establishment Name Address ID/FEI Business Operations Carilion Materials Management 079239644 REPACK(68151-1712)
