Label: MECLIZINE- meclizine hcl 25mg tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 66424-387-01, 66424-387-10 - Packager: SDA Laboratories, 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 February 1, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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
Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MECLIZINE
meclizine hcl 25mg tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66424-387 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) DEXTROSE (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color pink (LIGHT PINK COLOR) Score 2 pieces Shape ROUND (ROUND TABLET) Size 8mm Flavor Imprint Code PH051 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66424-387-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2018 2 NDC:66424-387-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 02/01/2018 Labeler - SDA Laboratories, Inc. (948067889) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 manufacture(66424-387) , pack(66424-387) , analysis(66424-387)
