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Meclizine HCl 25 mg by Proficient Rx LP

Medically reviewed on November 1, 2016

Dosage form: tablet, chewable
Ingredients: MECLIZINE HYDROCHLORIDE 25mg
Labeler: Proficient Rx LP
NDC Code: 63187-755

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

NDC 63187-755-30

Plus Pharma

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Meclizine HCl 25 mg

ANTIEMETIC

Treats and Prevents Motion Sickness

Prevents nausea, dizziness and vomiting

*Compare to the Active Ingredient in Bonine®

Raspberry

30 CHEWABLE TABLETS

25 mg each

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

CHEWABLE TABLETS

25 mg each

MECLIZINE HCL 25 MG 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-755(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 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
SODIUM SULFATE 
TRICALCIUM PHOSPHATE 
Product Characteristics
Colorpink (Uncoated) Score2 pieces
ShapeROUND (Biconvex) Size8mm
FlavorRASPBERRYImprint Code21G
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-755-3030 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
2NDC:63187-755-6060 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
3NDC:63187-755-9090 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33610/15/2015
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-755)

 
Proficient Rx LP

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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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