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Allergy Time by Time Cap Labs Inc

Dosage form: tablet
Ingredients: chlorpheniramine maleate 4mg
Labeler: Time Cap Labs Inc
NDC Code: 49483-242

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.

ALLERGY TIME 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
Product Characteristics
ColoryellowScore2 pieces
ShapeROUNDSize8mm
FlavorImprint CodeTCL242
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-242-00100000 TABLET (TABLET) in 1 CARTON
2NDC:49483-242-01100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
3NDC:49483-242-101000 TABLET (TABLET) in 1 BOTTLE, PLASTIC
4NDC:49483-242-2424 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/08/2011
Labeler - Time Cap Labs Inc (037052099)
Establishment
NameAddressID/FEIOperations
Time Cap Labs Inc037052099manufacture

Revised: 02/2011
 
Time Cap Labs Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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