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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242R CHLOR MAL

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-242
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColoryellowScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code TCL242
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-242-00100000 in 1 CARTON; Type 0: Not a Combination Product12/17/2018
2NDC:49483-242-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
3NDC:49483-242-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
4NDC:49483-242-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product12/17/2018
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/FEIBusiness Operations
Time Cap Labs Inc037052099manufacture(49483-242)

Revised: 12/2018
Document Id: 7d393588-61e4-0606-e053-2a91aa0a83b2
Set id: 588c424a-8dd6-417e-8f76-2ce0cc2b0c12
Version: 2
Effective Time: 20181217
 
Time Cap Labs Inc