Label: BONINE MAX- meclizine hydrochloride tablet, chewable
- NDC Code(s): 65197-520-16
- Packager: WellSpring Pharmaceutical Corporation
- 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 October 5, 2022
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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?
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SPL UNCLASSIFIED SECTION
NDC 65197-520-16
BONINE MAX STRENGTH
Prevents and treats: Dizziness - Nausea - Vomiting - Motion sickness
** Results may vary
ATTENTION: DO NOT USE IF CARTON IS OPEN OR IF BLISTER IS TORN OR MISSING. Keep carton for important drug facts information.
MONEY BACK GUARANTEED
Dist. by: WellSpring Pharmaceutical Corporation
Sarasota, FL 34243 USA© 2023 WellSpring Pharmaceutical Corporation
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BONINE MAX
meclizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65197-520 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) STARCH, CORN (UNII: O8232NY3SJ) PEPPERMINT (UNII: V95R5KMY2B) FD&C RED NO. 40 (UNII: WZB9127XOA) SACCHARIN SODIUM (UNII: SB8ZUX40TY) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor PEPPERMINT Imprint Code BMX Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65197-520-16 2 in 1 BOX 03/24/2023 1 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 final part336 03/24/2023 Labeler - WellSpring Pharmaceutical Corporation (110999054)