CAREONE ALLERGY RELIEF- chlorpheniramine maleate tablet 
American Sales Company

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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American Sales Company Allergy Relief Drug Facts

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:
sneezing
runny nose
itchy, watery eyes
itching of the nose or throat

Warnings

Do not use

to make a child sleepy

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble 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 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. (1-800-222-1222)

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

½ tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours

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

D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel

Compare to the Active Ingredient in Chlor-Trimeton® Allergy 4 Hour Tablets

ALLERGY RELIEF

Chlorpheniramine Maleate

4 HOUR ANTIHISTAMINE

Relieves:

Sneezing, Itchy, Watery Eyes,

Itchy Throat, Runny Nose

Allergy Relief Carton Image 1
Allergy Relief Carton Image 2
CAREONE ALLERGY RELIEF 
chlorpheniramine maleate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-463
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code L463
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-463-62 1 in 1 CARTON
1 24 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/18/2004
Labeler - American Sales Company (809183973)

Revised: 10/2012
Document Id: 2fe993ee-0e79-47cc-9460-5101371d610a
Set id: 2fe993ee-0e79-47cc-9460-5101371d610a
Version: 1
Effective Time: 20121004
 
American Sales Company