Label: DRAMAMINE- meclizine hydrochloride tablet, chewable
- NDC Code(s): 63029-906-12
- Packager: Medtech 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 July 5, 2019
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
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
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DRAMAMINE
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-906 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) FD&C RED NO. 40 (UNII: WZB9127XOA) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 9mm Flavor RASPBERRY (Raspberry cream) Imprint Code 258 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-906-12 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 02/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part336 02/15/2019 Labeler - Medtech Products Inc. (122715688)