Label: MECLIZINE HCL- meclizine hcl 25mg chewable tablets tablet, chewable
- NDC Code(s): 71610-528-30, 71610-528-60
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 54738-025
- 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 April 15, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
Ask a doctor before use if you have
- 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
- Keep out of reach of children.
- OTHER INFORMATION
- Questions or Comments
- Inactive ingredients
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count 25 mg 30 71610-0528-30 90 71610-0528-60
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Cookeville, TN 38506
- PRINCIPAL DISPLAY PANEL - 25 mg
INGREDIENTS AND APPEARANCE
meclizine hcl 25mg chewable tablets tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-528(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:71610-528-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/04/2021 2 NDC:71610-528-60 90 in 1 BOTTLE; Type 0: Not a Combination Product 03/04/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 05/01/2015 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-528)