CHLORPHENIRAMINE MALEATE 4 MG- chlorpheniramine maleate tablet 
REMEDYREPACK 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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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

  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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 tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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

  • each tablet contains: calsium 40 mg
  • store at 15°-30°C (59°-86°F)

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:

  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes

DRUG: Chlorpheniramine Maleate 4 mg

GENERIC: Chlorpheniramine Maleate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1540-0

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: AP;016

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CHLORPHENIRAMINE MALEATE 4mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • D&C YELLOW NO. 10
  • STARCH, PREGELATINIZED CORN
  • MAGNESIUM STEARATE
  • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
  • CROSCARMELLOSE SODIUM
  • SILICON DIOXIDE

Remedy_Label

CHLORPHENIRAMINE MALEATE 4 MG 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1540(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)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, PREGELATINIZED 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:70518-1540-030 in 1 BLISTER PACK; Type 0: Not a Combination Product10/16/2018
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/16/2018
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2019
Document Id: 946f3c1d-0351-d602-e053-2995a90a3d9a
Set id: 1b209446-57b3-400f-81fd-f4ce00e94cc1
Version: 3
Effective Time: 20191008
 
REMEDYREPACK INC.