Label: MECLIZINE HYDROCHLORIDE tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 71610-526-30, 71610-526-60 - Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 0536-1299
- 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 March 18, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- 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 enlarged prostate gland - Directions
- Other information
- INACTIVE INGREDIENT
- Questions or comments?
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SPL UNCLASSIFIED SECTION
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.
Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
www.rugbylaboratories.com -
Repackaging Information
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 71610-526-30 90 71610-526-60 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.
Repackaged by:
Cookeville, TN 38506
20210318JH - PRINCIPAL DISPLAY PANEL - 25 mg
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INGREDIENTS AND APPEARANCE
MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-526(NDC:0536-1299) 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 CROSPOVIDONE (UNII: 2S7830E561) VANILLA (UNII: Q74T35078H) MAGNESIUM STEARATE (UNII: 70097M6I30) RASPBERRY (UNII: 4N14V5R27W) STEARIC ACID (UNII: 4ELV7Z65AP) FD&C RED NO. 40 (UNII: WZB9127XOA) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color pink (Rosy) Score 2 pieces Shape ROUND Size 9mm Flavor VANILLA, RASPBERRY Imprint Code 5172 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71610-526-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2021 2 NDC:71610-526-60 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 10/30/2020 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-526)