Label: MECLIZINE HCL 25 MG- meclizine hydrochloride tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 53002-7650-1, 53002-7650-2, 53002-7650-3 - Packager: RPK Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 51645-994
- 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 16, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- HOW SUPPLIED
- Meclizine 25mg Chewtabs
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INGREDIENTS AND APPEARANCE
MECLIZINE HCL 25 MG
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53002-7650(NDC:51645-994) 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 ASPARTAME (UNII: Z0H242BBR1) SUCROSE (UNII: C151H8M554) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM SULFATE (UNII: 0YPR65R21J) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Product Characteristics Color pink (Uncoated) Score 2 pieces Shape ROUND (Biconvex) Size 8mm Flavor RASPBERRY Imprint Code 21G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53002-7650-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2018 2 NDC:53002-7650-1 10 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2018 3 NDC:53002-7650-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 10/15/2015 Labeler - RPK Pharmaceuticals, Inc. (147096275) Establishment Name Address ID/FEI Business Operations RPK Pharmaceuticals, Inc. 147096275 RELABEL(53002-7650) , REPACK(53002-7650)