Label: MECLIZINE 25- meclizine hydrochloride tablet, chewable
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NDC Code(s):
43063-804-01,
43063-804-06,
43063-804-12,
43063-804-20, view more43063-804-30
- Packager: PD-Rx Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
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 9, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients (in each chewable tablet)
- Purpose
- Indications and Usage
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Warnings
- Do not use for children under 12 years of age unless directed by a doctor.
Do not take unless directed by a doctor if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- Directions
- Inactive ingredients
- Questions?
- How Supplied
- PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label
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INGREDIENTS AND APPEARANCE
MECLIZINE 25
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43063-804 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 MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code PH;051 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43063-804-12 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/27/2017 11/30/2027 2 NDC:43063-804-20 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2018 11/30/2027 3 NDC:43063-804-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/08/2018 11/30/2027 4 NDC:43063-804-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/15/2018 11/30/2027 5 NDC:43063-804-06 6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/23/2018 11/30/2027 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 11/27/2017 11/30/2027 Labeler - PD-Rx Pharmaceuticals, Inc. (156893695) Registrant - PD-Rx Pharmaceuticals, Inc. (156893695) Establishment Name Address ID/FEI Business Operations PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-804)