MECLIZINE HCL 12.5 MG- meclizine hcl 12.5 mg tablet 
RPK 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

Warnings

Ask a docotor before use if you have

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

When using this product

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

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

When using this prodcut

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

Other information

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: 53002-6060

NDC: 53002-6060-1 10 TABLET in a BOTTLE

NDC: 53002-6060-2 20 TABLET in a BOTTLE

NDC: 53002-6060-3 30 TABLET in a BOTTLE

Meclizine HCl 12.5mg Tablets

Label Image
MECLIZINE HCL 12.5 MG 
meclizine hcl 12.5 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53002-6060(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:53002-6060-330 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
2NDC:53002-6060-110 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
3NDC:53002-6060-220 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33611/01/2015
Labeler - RPK Pharmaceuticals, Inc. (147096275)
Establishment
NameAddressID/FEIBusiness Operations
RPK Pharmaceuticals, Inc.147096275RELABEL(53002-6060) , REPACK(53002-6060)

Revised: 12/2020
Document Id: f6eedef5-f3fc-4e09-b9a0-0decbc147df4
Set id: b442caed-926b-4331-92b8-cefc967f21ac
Version: 3
Effective Time: 20201216
 
RPK Pharmaceuticals, Inc.