ALLERGY RELIEF- 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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Active ingredient (in each tablet)

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:

                -runny nose

                -sneezing               

                -itching of the nose and throat

                -itchy, watery eyes

Warnings

Ask a doctor before use if you have

• glaucoma

• trouble urinating due to an enlarged prostate gland

• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if youare taking sedatives or tranquilizers

When using this product

• drowsiness may occur

• avoid alcoholic drinks

• alcohol, sedatives and tranquilizers may increase drowsiness

• excitability may occur, especially in children

• use caution 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

  • do not exceed recommended dose
  • adults and children 12 years and over: take 1 tablet every 4 to 6
    hours, as needed, not more than 6 tablets in 24 hours or as directed by a doctor
  • children under 12 years: consult a doctor

Other information

  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • store at room temperature 
  • protect from moisture

Inactive ingredients

cellulose, croscarmellose sodium, D and C yellow no. 10 lake, lactose, magnesium stearate, silica, stearic acid.

HOW SUPPLIED

Product: 71335-1015

NDC: 71335-1015-1 30 TABLET in a BOTTLE

NDC: 71335-1015-2 60 TABLET in a BOTTLE

NDC: 71335-1015-3 100 TABLET in a BOTTLE

NDC: 71335-1015-4 120 TABLET in a BOTTLE

NDC: 71335-1015-5 40 TABLET in a BOTTLE

Chlorpheniramine Maleate 4mg Tablet

Label Image
ALLERGY RELIEF 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1015(NDC:57896-784)
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColoryellowScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code TCL242
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-1015-130 in 1 BOTTLE; Type 0: Not a Combination Product10/12/200505/01/2021
2NDC:71335-1015-260 in 1 BOTTLE; Type 0: Not a Combination Product10/12/200505/01/2021
3NDC:71335-1015-3100 in 1 BOTTLE; Type 0: Not a Combination Product10/12/200505/01/2021
4NDC:71335-1015-4120 in 1 BOTTLE; Type 0: Not a Combination Product10/12/200505/01/2021
5NDC:71335-1015-540 in 1 BOTTLE; Type 0: Not a Combination Product10/12/200505/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/200405/01/2021
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-1015) , RELABEL(71335-1015)

Revised: 3/2022
Document Id: 6d005729-843a-4726-a451-6824a3f41910
Set id: b6afa521-55ea-455b-b43b-2f3c8469d60f
Version: 4
Effective Time: 20220301
 
Bryant Ranch Prepack