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Meclizine HCl 25 mg by RedPharm Drug, Inc.

Medically reviewed on October 16, 2017

Dosage form: tablet, chewable
Ingredients: MECLIZINE HYDROCHLORIDE 25mg
Labeler: RedPharm Drug, Inc.
NDC Code: 67296-1390

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.

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

WARNINGS

DO NOT USE

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

ASK 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 DOCTOR/PHARMACIST

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

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

OTHER SAFETY INFORMATION

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.

SPL UNCLASSIFIED SECTION

WHEN USING

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

PURPOSE

Antiemetic

PRINCIPAL DISPLAY PANEL

MECLIZINE HCL 25 MG 
meclizine hcl 25 mg tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1390(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
CROSCARMELLOSE SODIUM 
FD&C RED NO. 40 
CELLULOSE, MICROCRYSTALLINE 
TRICALCIUM PHOSPHATE 
ASPARTAME 
SUCROSE 
DEXTROSE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
SILICON DIOXIDE 
SODIUM SULFATE 
Product Characteristics
Colorpink (uncoated) Score2 pieces
ShapeROUND (bioconvex) Size8mm
FlavorRASPBERRYImprint Code21G
Contains    
Packaging
#Item CodePackage Description
1NDC:67296-1390-330 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33610/15/2015
Labeler - RedPharm Drug, Inc. (828374897)
Establishment
NameAddressID/FEIOperations
RedPharm Drug, Inc.828374897repack(67296-1390), relabel(67296-1390)

 
RedPharm Drug, Inc.

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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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