Label: MECLIZINE- meclizine hydrochloride tablet, chewable
- NDC Code(s): 80513-421-02
- Packager: Advanced Rx LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 27, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
Do not use in children under 12 years of age unless directed by a doctor.
Do not take unless directed by a doctor if you have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Do not take this product if you aretaking sedatives or tranquilizers, without first consulting your doctor.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL
NDC 80513-421-02
*Compare to the active ingredient in Bonine ®
Meclizine HCl 25 mg
Raspberry Flavor
Antiemetic
• Motion Sickness
• Vomiting
• Nausea
200 CHEWABLE TABLETS
*This product is not manufactured or distributed by WellSpring Pharmaceuticals Corporation., owner of the registered trademark Bonine ®
Distributed by:
ADVANCED RX LLC,
1942 NE 163rd St
North Miami Beach, FL 33162 U.S.A.
Manufactured in the USA
-
INGREDIENTS AND APPEARANCE
MECLIZINE
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80513-421 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) RASPBERRY (UNII: 4N14V5R27W) 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:80513-421-02 200 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M009 12/01/2024 Labeler - Advanced Rx LLC (042795108) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 manufacture(80513-421) , pack(80513-421) , analysis(80513-421) , label(80513-421)