Label: MECLIZINE HYDROCHLORIDE tablet, chewable
- NDC Code(s): 82982-036-30
- Packager: Pharmasource Meds, 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 April 14, 2023
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?
-
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation, owner of the registered trademark Bonine®.
Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268Please reference the "Other information" section listed above for storage information. This drug product has been received by Pharmasource Meds, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable GMP regulations. The drug product is repackaged and labeled for single patient use to be dispensed within a pharmacy setting as a single patient prescription.
www.rugbylaboratories.comRepackaged by:
Pharmasource Meds, LLC
Tigard, OR 97223 - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82982-036(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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C RED NO. 40 (UNII: WZB9127XOA) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 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:82982-036-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/14/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M009 04/14/2023 Labeler - Pharmasource Meds, LLC (118772692)