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Meclizine HCl 25 mg by Unit Dose Services

Medically reviewed on December 5, 2017

Dosage form: tablet, chewable
Ingredients: MECLIZINE HYDROCHLORIDE 25mg
Labeler: Unit Dose Services
NDC Code: 50436-0994

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.

Meclizine HCl 25 mg Chewable Tablets

Active ingredient (in each chewable tablet)

Meclizine HCl, USP 25 mg

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness

Warnings

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

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

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 the poison control center immediately.

Directions
  • Dosage should be taken one hour before travel starts.
  • Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
  • Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.

Other information
  • store at room temperature

  • Phenylketonurics: Contains phenylalanine 0.28 mg per tablet
  • Do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

Questions or comments?

If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

Distributed by: Plus Pharma, Commack, NY 11725

*Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.

When using this product

  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery

MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE
MECLIZINE HCL 25 MG 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-0994(NDC:51645-994)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
SUCROSE 
CROSCARMELLOSE SODIUM 
DEXTROSE, UNSPECIFIED FORM 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
MALTODEXTRIN 
MICROCRYSTALLINE CELLULOSE 
SILICON DIOXIDE 
SODIUM SULFATE 
TRICALCIUM PHOSPHATE 
Product Characteristics
Colorpink (Uncoated) Score2 pieces
ShapeROUND (Biconvex) Size8mm
FlavorRASPBERRYImprint Code21G
Contains    
Packaging
#Item CodePackage Description
1NDC:50436-0994-130 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33610/15/2015
Labeler - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIOperations
Unit Dose Services831995316REPACK(50436-0994), RELABEL(50436-0994)

 
Unit Dose Services

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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