Label: BONINE- meclizine hydrochloride tablet, chewable
- NDC Code(s): 65197-297-08, 65197-297-12, 65197-297-16, 65197-297-24
- Packager: WellSpring Pharmaceutical Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 21, 2025
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Dist. by:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 65197-297
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INGREDIENTS AND APPEARANCE
BONINE
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65197-297 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) FD&C RED NO. 40 (UNII: WZB9127XOA) SACCHARIN SODIUM (UNII: SB8ZUX40TY) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color pink Score 2 pieces Shape ROUND Size 9mm Flavor RASPBERRY Imprint Code BONINE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65197-297-08 1 in 1 BOX 04/01/2025 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:65197-297-12 1 in 1 BOX 04/01/2025 2 12 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:65197-297-16 2 in 1 BOX 04/01/2025 3 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:65197-297-24 3 in 1 CARTON 04/01/2025 4 8 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M009 04/01/2025 Labeler - WellSpring Pharmaceutical Corporation (110999054)