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Allergy Time by Bryant Ranch Prepack

Medically reviewed on December 28, 2017

Dosage form: tablet
Ingredients: CHLORPHENIRAMINE MALEATE 4mg
Labeler: Bryant Ranch Prepack
NDC Code: 71335-0061

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.


Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg

Purpose: Antihistamine




Uses: temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:

runny nose, sneezing, itching of the nose or throat, itch, watery eyes

Warnings

Ask a doctor before use if you have:

glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty 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:

excitability may occur, especially in children; drowsiness may occur; avoid alcoholic beverages; alcohol, sedatives and tranquilizers may increase drowsiness; use caution when driving a motor vehicle operating machinery


If pregnant or breast-feeding ask a health professional before use.

Directions

Adults and children 12 years and over - 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours

Children 6 to under 12 years of age - 1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours

Children under 6 years of age - do not use

Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.

HOW SUPPLIED

Product: 71335-0061

NDC: 71335-0061-3 100 TABLET in a BOTTLE

NDC: 71335-0061-1 30 TABLET in a BOTTLE

NDC: 71335-0061-4 120 TABLET in a BOTTLE

NDC: 71335-0061-2 60 TABLET in a BOTTLE

Chlorpheniramine Maleate 4mg Tablet
ALLERGY TIME 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0061(NDC:49483-242)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
STEARIC ACID 
Product Characteristics
ColoryellowScore2 pieces
ShapeROUNDSize8mm
FlavorImprint CodeTCL242
Contains    
Packaging
#Item CodePackage Description
1NDC:71335-0061-3100 TABLET in 1 BOTTLE
2NDC:71335-0061-130 TABLET in 1 BOTTLE
3NDC:71335-0061-4120 TABLET in 1 BOTTLE
4NDC:71335-0061-260 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/08/2011
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK(71335-0061), RELABEL(71335-0061)

 
Bryant Ranch Prepack

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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