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Drug Facts
Dist. by: INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749
Bonine
FDA Label NDC 63736-124
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals for the product Bonine (NDC 63736-124). 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 other, active ingredient (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Meclizine HCl 25 mg
Purpose
Antiemetic
Uses
prevents and treats nausea, vomiting or dizziness associated with motion sickness
Otc - Do Not Use
Do not use for children under 12 years of age unless directed by a doctor
Otc - Ask Doctor
Do not take 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 if you are taking sedatives or tranquilizers, without first consulting your doctor.
Otc - When Using
When using this product
- do not exceed recommended dosage
- drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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
- adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor
Other Information
store at room temperature 20°– 25°C (68°–77°F)
Inactive Ingredients
Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid, Vanilla Flavor.
Questions?
call 1-800-344-7239 or visit us on the web at www.insightpharma.com
Principal Display Panel - 8 Tablet Carton
BONINE®
MECLIZINE HYDROCHLORIDE • ANTIEMETIC
Prevents Motion Sickness
Chewable
Once-A-Day
Protection
8 Tablets
Principal Display Panel (8 Tablet Carton)
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