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

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63736-124
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
meclizine hydrochloride (meclizine) meclizine25 mg
Inactive Ingredients
Ingredient NameStrength
crospovidone 
FD&C Red No. 40 
Aluminum Oxide 
Lactose 
Magnesium Stearate 
Silicon Dioxide 
Saccharin Sodium 
stearic acid 
Croscarmellose Sodium 
Product Characteristics
ColorPINK (light pink) Score2 pieces
ShapeROUNDSize9mm
FlavorRASPBERRY, VANILLAImprint Code Bonine;201
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-124-088 in 1 BOX
2NDC:63736-124-1212 in 1 BOX
3NDC:63736-124-1616 in 1 BOX
4NDC:63736-124-2121 in 1 BOX
5NDC:63736-124-952 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33606/08/2009
Labeler - Insight Pharmaceuticals (176792315)

Revised: 1/2010
Document Id: 82885c3d-4964-44dd-8bb6-fe55afab3ce7
Set id: 0b4b55cd-063e-4d0e-911c-8e03886e15d3
Version: 2
Effective Time: 20100111
 
Insight Pharmaceuticals