MECLIZINE HCL 12.5 MG- meclizine hcl 12.5 mg tablet 
Preferred Pharmaceuticals Inc.

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.

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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

Repackaged By: Preferred Pharmaceuticals Inc.

www.reliable1labs.com

NDC 68788-6956

Meclizine HCL 12.5 mg

ANTIEMETIC

Meclizine HCL 12.5mg Caplets
MECLIZINE HCL 12.5 MG 
meclizine hcl 12.5 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-6956(NDC:69618-027)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize13mm
FlavorImprint Code AP;117
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-6956-110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/02/201707/15/2021
2NDC:68788-6956-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/02/201707/15/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33605/02/201707/15/2021
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-6956)

Revised: 7/2021
 
Preferred Pharmaceuticals Inc.