Label: MECLIZINE HCL- meclizine hcl 25mg chewable tablets tablet, chewable
- NDC Code(s): 54738-025-01, 54738-025-03
- Packager: Richmond Pharmaceuticals, 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 October 30, 2017
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an elarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- you may get drowsy
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increse drowsiness
- be careful when driving a moor vehicle or operating machinery
- Directions
- Keep out of reach of children.
- OTHER INFORMATION
- Questions or Comments
- Inactive ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
MECLIZINE HCL
meclizine hcl 25mg chewable tablets tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54738-025 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DEXTROSE (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) RASPBERRY (UNII: 4N14V5R27W) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SUCROSE (UNII: C151H8M554) Product Characteristics Color red Score 2 pieces Shape ROUND Size 8mm Flavor RASPBERRY Imprint Code AP;115 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54738-025-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2015 2 NDC:54738-025-03 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 05/01/2015 Labeler - Richmond Pharmaceuticals, Inc. (043569607) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(54738-025)
