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


BONINE® MECLIZINE HYDROCHLORIDE • ANTIEMETIC

BONINE - meclizine 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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BONINE®
MECLIZINE HYDROCHLORIDE • ANTIEMETIC

Drug Facts

Active ingredient (in each tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

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

Warnings

Do not use for children under 12 years of age unless directed by a 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.

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

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

  • 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

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

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

BONINE 
meclizine hydrochloride tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-124
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
meclizine hydrochloride (meclizine) meclizine 25 mg
Inactive Ingredients
Ingredient Name Strength
crospovidone  
FD&C Red No. 40  
Aluminum Oxide  
Lactose  
Magnesium Stearate  
Silicon Dioxide  
Saccharin Sodium  
stearic acid  
Croscarmellose Sodium  
Product Characteristics
Color PINK (light pink) Score 2 pieces
Shape ROUND Size 9mm
Flavor RASPBERRY, VANILLA Imprint Code Bonine;201
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-124-08 8 TABLET, CHEWABLE ( TABLET) in 1 BOX None
2 NDC:63736-124-12 12 TABLET, CHEWABLE ( TABLET) in 1 BOX None
3 NDC:63736-124-16 16 TABLET, CHEWABLE ( TABLET) in 1 BOX None
4 NDC:63736-124-21 21 TABLET, CHEWABLE ( TABLET) in 1 BOX None
5 NDC:63736-124-95 2 TABLET, CHEWABLE ( TABLET) in 1 POUCH 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: 01/2010 Insight Pharmaceuticals



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


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