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Name:Allergy Time
Manufacturer:Time Cap Labs Inc
Category:Over-the-counter (OTC) Marketed Drugs


ALLERGY TIME  - chlorpheniramine maleate tablet 
Time Cap Labs 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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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.

100 CT LABEL


ALLERGY TIME 
chlorpheniramine maleate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-242
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
chlorpheniramine maleate (CHLORPHENIRAMINE ) chlorpheniramine maleate 4 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
STEARIC ACID  
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code TCL242
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49483-242-00 100000 TABLET ( TABLET) in 1 CARTON None
2 NDC:49483-242-01 100 TABLET ( TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:49483-242-10 1000 TABLET ( TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:49483-242-24 24 TABLET ( TABLET) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 02/08/2011

Labeler - Time Cap Labs Inc (037052099)
Establishment
Name Address ID/FEI Operations
Time Cap Labs Inc 037052099 manufacture

Revised: 02/2011 Time Cap Labs Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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