Label: DRAMAMINE ORIGINAL FORMULA- dimenhydrinate tablet
- NDC Code(s): 63029-901-01, 63029-901-02, 63029-901-03
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 27, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
-
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
- a breathing problem such as emphysema or chronic bronchitis
-
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:
Adults and
children 12
years and over- take 1 to 2 tables every 4-6 hours
- do not take more than 8 tablets in
24 hours, or as directed by a doctor
Children 6 to
under 12 years- give ½ to 1 tablet every 6-8 hours
- do not give more than 3 tablets in
24 hours, or as directed by a doctor
Children 2 to
under 6 years- give ½ tablet every 6-8 hours
- do not give more than 1 ½ 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 or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DRAMAMINE ORIGINAL FORMULA
dimenhydrinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-901 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (8-CHLOROTHEOPHYLLINE - 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) CELLULOSE, MICROCRYSTALLINE (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:63029-901-01 3 in 1 BOX 01/15/2012 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63029-901-02 1 in 1 BOX 01/15/2012 2 12 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:63029-901-03 1 in 1 CARTON 01/15/2012 3 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 Drug M009 01/15/2012 Labeler - Medtech Products Inc. (122715688)