Label: MECLIZINE- meclizine hcl 25mg tablet, chewable
- NDC Code(s): 68071-4584-2
- Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 66424-387
- 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.
Updated April 4, 2019
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- Active ingredient (in each tablet)
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
- 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.
When using this product
- do not exceed recommended dosage
- drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
meclizine hcl 25mg tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-4584(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:68071-4584-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 04/04/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 02/01/2018 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NUCARE PHARMACEUTICALS INC 010632300 repack(68071-4584)