Active Ingredient (In Each Tablet)
Meclizine HCl 25 mg
Bonine Tablet, Chewable
FDA Label NDC 65197-296
20 label sections · Submitted to the FDA by Wellspring Pharmaceutical Corporation · 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 65197-296). 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, do not take this product, unless directed by a doctor, if you have, do not take this product 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.
Do Not Take This Product, Unless Directed By A Doctor, If You Have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Do Not Take This Product If You Are
taking sedatives or tranquilizers, without first consulting your doctor.
When Using This Product
- do not exceed recommended dosage
- you may get drowsy
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful 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 (65197-275)
- dosage should be taken one hour before travel starts
- adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor
Directions (65197-296)
- 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
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (65197-275)
croscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor.
Inactive Ingredients (65197-296)
corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide
Questions?
1 (844) 241-5454 or www.bonine.com
Tamper Evident 65197-275
TAMPER EVIDENT: DO NOT USE IF TAMPER EVIDENCE TAPE OVER CAP IS BROKEN OR MISSING.
Tamper Evident 65197-296
ATTENTION: DO NOT USE IF CARTON IS OPEN OR IF BLISTER IS TORN OR MISSING.
Keep Carton for important drug facts information.
Dist. By:
WellSpring Pharmaceutical
Corporation Sarasota, FL 34243
©2023 WellSpring Pharmaceutical Corporation
Package Label.Principal Display Panel 65197-275
UP TO 24 HOUR PROTECTION
BONINE®
MECLIZINE HYDROCHLORIDE • ANTIEMETIC
Nausea - Dizziness - Vomiting
*Less drowsy than Dramamine
Bonine 12 Ct (Bonine 1)
Package Label.Principal Display Panel 65197-296
NEW LOOK! Same great formula
9X the Adventure**
**Results may vary.
Meclizine HCL • Antiemetic 25mg
*Less drowsy than Dramamine ®
BONINE®
MECLIZINE HCL
Prevents & Treats: Motion Sickness / Nausea & Vomiting / Dizziness / Cyber Sickness
Up to 24 Hours Relief
Bonine 8ct Blue New Design (Bonine 2)
* Please review the disclaimer below.
