Active Ingredient (In Each Tablet)
Meclizine HCl 25 mg
Bonine Tablet, Chewable
FDA Label NDC 65197-297
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wellspring Pharmaceutical Corporation for the product Bonine (NDC 65197-297). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiemetic
Uses
prevents and treats nausea, vomiting or dizziness associated with motion sickness
Do Not Use
in children under 12 years of age unless directed by a doctor.
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
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- drowsiness may occur
- use caution when driving a motor vehicle or operating machinery
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- dosage should be taken one hour before travel starts
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor
Other Information
- store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)
- see end flap for expiration date and lot number
- protect from heat and humidity
Inactive Ingredients
colloidal silicon dioxide, dextrose, FD&C red #40 aluminum lake, flavor, lactose monohydrate, magnesium stearate, pregelatinized starch, propylene glycol, saccharin sodium, silicon dioxide
Questions Or Comments?
1 (844) 241-5454 or www.bonine.com
Dist. By:
WellSpring Pharmaceutical
Corporation Sarasota, FL 34243
©2024 WellSpring Pharmaceutical Corporation
TAMPER EVIDENT: DO NOT USE IF PRINTED TEAR STRIP IS BROKEN OR MISSING
MONEY BACK GUARANTEE
Package Label.Principal Display Panel 65197-297
*Less drowsy vs. Dramamine® dimenhydrinate. Dramamine® is a registered trademark of Medtech Products Inc.
NEW LOOK! Same great formula
9X the Adventure** Meclizine HCl • Antiemetic 25 mg
Ct029512re (Bonine Chewable Tablets 1)
* Please review the disclaimer below.
