TOPCARE ALLERGY- chlorpheniramine maleate tablet 
Topco Associates LLC

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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Topco Allergy Drug Facts

Active ingredient (in each tablet)

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy nose or throat
itchy, watery eyes

Warnings

Do not use

to make a child sleepy

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 you are

taking sedatives or tranquilizers

When using this product

alcohol, sedatives and tranquilizers may increase drowsiness
drowsiness may occur
avoid alcoholic drinks
excitability may occur, especially in children
be careful 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

take every 4 to 6 hours, not more than 6 doses in 24 hours

adults and children 12 years of age and over

1 tablet (4 mg)

children 6 to under 12 years of age

1/2 tablet (2 mg)

children 4 to under 6 years of age

do not use unless

directed by a doctor

children under 4 years of age

do not use

Inactive ingredients

corn starch, D&C yellow no. 10, lactose, magnesium stearate

Questions or comments?

1-888-423-0139

Principal Display Panel

See New Warning and Dosing Directions

For Fast-Acting Relief

Allergy

Chlorpheniramine Maleate

Antihistamine

4 Hour Relief

Relieves: Runny Nose, Sneezing, Itchy, Watery Eyes, Itchy Throat

Actual Size

Compare to Chlor-Trimeton® active ingredient

Allergy Carton

Allergy Carton

Allergy Carton

TOPCARE ALLERGY 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-463
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorYELLOWScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code L463
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-463-621 in 1 CARTON10/06/199504/01/2016
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/06/199504/01/2016
Labeler - Topco Associates LLC (006935977)

Revised: 11/2017
 
Topco Associates LLC