Label: MECLIZINE HYDROCHLORIDE- meclizine hcl tablet, chewable
- NDC Code(s): 80136-779-01
- Packager: NORTHEAST PHARMA
- 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 November 22, 2022
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- Active ingredient (in each chewable tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- glaucoma
- breathing problems, such as emphysema or chronic bronchitis
- difficulty urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
MECLIZINE HYDROCHLORIDE
meclizine hcl tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80136-779 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 STARCH, CORN (UNII: O8232NY3SJ) FD&C RED NO. 40 (UNII: WZB9127XOA) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color pink Score 2 pieces Shape ROUND Size 9mm Flavor RASPBERRY Imprint Code 44;404 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80136-779-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 11/01/2022 Labeler - NORTHEAST PHARMA (081232935) Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)