CHLORPHENIRAMINE MALEATE 4 MG- chlorpheniramine maleate tablet 
Bryant Ranch Prepack

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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Chlorpheniramine Maleate 4 mg

Drug Facts

Active ingredient (in each tablet)

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Warnings

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 product

Drug Facts continued on back of label

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 and children 12 years and overtake 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
children 6 years to under 12 yearstake 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours
children under 6 yearsdo not use

Other information

Inactive ingredients

croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

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

* Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Chlor-Trimeton®

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

www.reliable1labs.com

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

HOW SUPPLIED

NDC: 71335-0963-1: 30 Tablets in a BOTTLE

NDC: 71335-0963-2: 60 Tablets in a BOTTLE

NDC: 71335-0963-3: 100 Tablets in a BOTTLE

NDC: 71335-0963-4: 120 Tablets in a BOTTLE

NDC: 71335-0963-5: 40 Tablets in a BOTTLE

Chlorpheniramine Maleate 4mg Tablet

Label
CHLORPHENIRAMINE MALEATE 4 MG 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0963(NDC:69618-022)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint Code AP;016
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0963-130 in 1 BOTTLE; Type 0: Not a Combination Product10/05/2018
2NDC:71335-0963-260 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
3NDC:71335-0963-3100 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
4NDC:71335-0963-4120 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
5NDC:71335-0963-540 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/2015
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0963) , RELABEL(71335-0963)

Revised: 2/2022
Document Id: 54681242-c861-4415-b5c0-d3ab55b62be1
Set id: 54681242-c861-4415-b5c0-d3ab55b62be1
Version: 7
Effective Time: 20220214
 
Bryant Ranch Prepack