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Name:Boninekids
Manufacturer:Insight Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


CHEWABLE TRAVEL TABLETBONINE®FOR KIDS

BONINE KIDS - chlorcyclizine hydrochloride tablet, chewable 
Insight Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CHEWABLE TRAVEL TABLET
BONINE®
FOR KIDS

ATTENTION: USE ONLY IF TABLET BLISTER SEALS ARE UNBROKEN.

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

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

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

Drug Facts

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 8 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

PRINCIPAL DISPLAY PANEL - Box of 12 Tablets

BONINE  KIDS
chlorcyclizine hydrochloride tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-044
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Chlorcyclizine Hydrochloride (Chlorcyclizine) Chlorcyclizine 25 mg
Inactive Ingredients
Ingredient Name Strength
Crospovidone  
FD&C Red No. 40  
Aluminum Oxide  
Lactose  
Magnesium Stearate  
Silicon Dioxide  
Saccharin Sodium  
Stearic Acid  
vanilla  
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 14mm
Flavor BERRY Imprint Code Bonine
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-044-08 8 TABLET, CHEWABLE ( TABLET) in 1 BOX None
2 NDC:63736-044-12 12 TABLET, CHEWABLE ( TABLET) in 1 BOX None

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)

Revised: 06/2009 Insight Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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