Bonine
FDA Label NDC 63736-044

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 63736-044). 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, otc - questions, otc - active ingredient, uses, otc - do not use, otc - ask doctor, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Questions

→ Otc - Active Ingredient

→ Uses

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - Box Of 8 Tablets

→ Principal Display Panel - Box Of 12 Tablets

Other

ATTENTION: USE ONLY IF TABLET BLISTER SEALS ARE UNBROKEN.

Distr. by: INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

*DRAMAMINE is a registered trademark of McNEIL-PPC, Inc.

Drug Facts

Otc - Questions

Questions? Call 1-800-344-7239
www.insightpharma.com

Otc - Active Ingredient

Active ingredient (in each tablet)	Purpose
Cyclizine HCl 25 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Otc - Do Not Use

Do not use in children under 6 years of age unless directed by a doctor

Otc - Ask Doctor

Do not take or give to children if they have a breathing problem such as chronic bronchitis or glaucoma without first consulting a doctor

Do not take or give to children if they are taking sedatives or tranquilizers without first consulting a doctor

Otc - When Using

When using this product

do not exceed recommended dosage
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

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

children 6 years of age and older: chew 1 tablet thoroughly every 6 to 8 hours
do not exceed 3 tablets in 24 hours or as directed by a doctor
dosage should be taken up to one hour before travel starts or at onset of symptoms

Other Information

store at room temperature 20°–25°C (86°–77°F)

Inactive Ingredients

Croscarmellose Sodium, Ethylcellulose, D&C Red #27 Lake, FD&C Blue #2 Lake, Hydroxypropylcellulose, Hypromellose, Magnesium Stearate, Mannitol, N&A Flavors, Sorbitol, Sucralose