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BONINE by WellSpring Pharmaceutical Corporation

Medically reviewed on April 20, 2017

Dosage form: tablet, chewable
Ingredients: MECLIZINE HYDROCHLORIDE 25mg
Labeler: WellSpring Pharmaceutical Corporation
NDC Code: 65197-275

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.

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 in children under 12 years of age unless directed by a doctor.

Do not take this product, 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 this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

  • do not exceed recommended dosage
  • you may get drowsy
  • 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 1 (800) 222-1222

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 toll-free 1 (844) 241-5454 or visit us on the web at www.bonine.com

ATTENTION:  DO NOT USE IF CARTON IS OPEN OR IF BLISTER IS TORN OR MISSING. 

Dist. by: WellSpring Pharmaceutical Corporation
Sarasota, FL 34243 USA © WellSpring 2014

PRINCIPAL DISPLAY PANEL 65197-275

Principal Display Panel 65197-296
BONINE 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-275
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
FD&C RED NO. 40 
LACTOSE 
MAGNESIUM STEARATE 
SILICON DIOXIDE 
SACCHARIN SODIUM 
STEARIC ACID 
CROSCARMELLOSE SODIUM 
Product Characteristics
ColorPINK (light pink) Score2 pieces
ShapeROUNDSize9mm
FlavorRASPBERRY, VANILLAImprint CodeBonine;201
Contains    
Packaging
#Item CodePackage Description
1NDC:65197-275-081 BLISTER PACK in 1 BOX
18 TABLET, CHEWABLE in 1 BLISTER PACK
2NDC:65197-275-162 BLISTER PACK in 1 BOX
28 TABLET, CHEWABLE in 1 BLISTER PACK
3NDC:65197-275-121 BOTTLE in 1 BOX
312 TABLET, CHEWABLE in 1 BOTTLE
4NDC:65197-275-022 TABLET, CHEWABLE in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/15/2014
BONINE 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-296
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
LACTOSE 
MAGNESIUM STEARATE 
SACCHARIN SODIUM 
STARCH, CORN 
SILICON DIOXIDE 
Product Characteristics
ColorPINKScore2 pieces
ShapeROUNDSize9mm
FlavorRASPBERRYImprint CodeBonine;201
Contains    
Packaging
#Item CodePackage Description
1NDC:65197-296-081 BLISTER PACK in 1 BOX
18 TABLET, CHEWABLE in 1 BLISTER PACK
2NDC:65197-296-162 BLISTER PACK in 1 BOX
28 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33604/18/2017
Labeler - WellSpring Pharmaceutical Corporation (110999054)

 
WellSpring Pharmaceutical Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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