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Meclizine HCL 12.5 mg by Bryant Ranch Prepack

Medically reviewed on Jan 1, 2018

Dosage form: tablet
Ingredients: MECLIZINE HYDROCHLORIDE 12.5mg
Labeler: Bryant Ranch Prepack
NDC Code: 71335-0615

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 12.5

Drug Facts

Active indredient (in each caplet)

Meclizine HCL 12.5 mg

Purpose

Antiemetic

Uses
  • prevents and treats nausea, vomiting, or dizziness due to motion sickness
  • for other uses, consult your doctor

Warnings

Ask a docotor 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

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquillizers may increase drowsiness
  • 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.

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

When using this prodcut

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranqulizers may increase drowsiness
  • 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
  • adults & children 12 years and over: 2-4 caplets once daily
  • children under 12 years: ask a doctor

Other information
  • each caplet contains: calcium 51 mg
  • store at room temperature 15º-30ºC (59º-86ºF)
  • This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Reliable 1 Laboratoires LLC, Valley Stream, NY 11580

www.reliable1labs.com

HOW SUPPLIED

Product: 71335-0615

NDC: 71335-0615-3 90 TABLET in a BOTTLE

NDC: 71335-0615-6 120 TABLET in a BOTTLE

NDC: 71335-0615-1 30 TABLET in a BOTTLE

NDC: 71335-0615-4 28 TABLET in a BOTTLE

NDC: 71335-0615-5 20 TABLET in a BOTTLE

NDC: 71335-0615-2 60 TABLET in a BOTTLE

Meclizine Hcl 12.5mg Tablet
MECLIZINE HCL 12.5 MG 
meclizine hcl 12.5 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0615(NDC:69618-027)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
STEARIC ACID 
MICROCRYSTALLINE CELLULOSE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize13mm
FlavorImprint CodeAP;117
Contains    
Packaging
#Item CodePackage Description
1NDC:71335-0615-390 TABLET in 1 BOTTLE
2NDC:71335-0615-6120 TABLET in 1 BOTTLE
3NDC:71335-0615-130 TABLET in 1 BOTTLE
4NDC:71335-0615-428 TABLET in 1 BOTTLE
5NDC:71335-0615-520 TABLET in 1 BOTTLE
6NDC:71335-0615-260 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33611/01/2015
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK(71335-0615), RELABEL(71335-0615)

 
Bryant Ranch Prepack

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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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