BONINE KIDS- chlorcyclizine hydrochloride tablet, chewable

Bonine by

Drug Labeling and Warnings

Bonine by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ATTENTION: USE ONLY IF TABLET BLISTER SEALS ARE UNBROKEN.

QUESTIONS

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

SPL UNCLASSIFIED SECTION

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

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

Drug Facts

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

Warnings

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

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

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

PRINCIPAL DISPLAY PANEL - Box of 8 Tablets

CHEWABLE TRAVEL TABLET
BONINE®

CYCLIZINE HYDROCHLORIDE ANTIEMETIC

FOR KIDS
The Product to Use at the Onset of Symptoms

Berry Blast

8 Chewable Tablets

PRINCIPAL DISPLAY PANEL - Box of 12 Tablets

BONUS 50% MORE
12 TABLETS FOR THE PRICE OF 8 TABLETS

CHEWABLE TRAVEL TABLET
BONINE®

CYCLIZINE HYDROCHLORIDE ANTIEMETIC

FOR KIDS
The Product to Use at the Onset of Symptoms

Berry Blast

12 Chewable Tablets

INGREDIENTS AND APPEARANCE

BONINE  KIDS
chlorcyclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-044
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlorcyclizine Hydrochloride (UNII: NPB7A7874U) (Chlorcyclizine - UNII:M26C4IP44P)	Chlorcyclizine	25 mg

Inactive Ingredients
Ingredient Name	Strength
Crospovidone (UNII: 68401960MK)
FD&C Red No. 40 (UNII: WZB9127XOA)
Aluminum Oxide (UNII: LMI26O6933)
Lactose (UNII: J2B2A4N98G)
Magnesium Stearate (UNII: 70097M6I30)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Saccharin Sodium (UNII: SB8ZUX40TY)
Stearic Acid (UNII: 4ELV7Z65AP)
vanilla (UNII: Q74T35078H)

Product Characteristics
Color	PINK	Score	2 pieces
Shape	ROUND	Size	14mm
Flavor	BERRY	Imprint Code	Bonine
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-044-08	8 in 1 BOX
2	NDC: 63736-044-12	12 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	06/08/2009

Labeler - Insight Pharmaceuticals (176792315)