COMPLETE ALLERGY RELIEF 4-HOUR- chlorpheniramine maleate tablet, coated

Complete Allergy Relief 4-Hour by

Drug Labeling and Warnings

Complete Allergy Relief 4-Hour by is a Otc medication manufactured, distributed, or labeled by SMART SENSE (KMART). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)	Purpose
Chlorpheniramine maleate 4 mg	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

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 under 6 years of age: ask a doctor

Other information

• store at 20°-25°C (68°-77°F) in a dry place
• retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid

PRINCIPAL DISPLAY PANEL

Smart Sense™

Compare to active ingredient in Chlor-Trimeton® Allergy 4-Hour†

Complete Allergy Relief

Chlorpheniramine Maleate, 4 mg Antihistamine

4-hour

Relieves:

Sneezing Itchy, Watery Eyes

Runny Nose Itchy Throat

24 Tablets 

4 mg Each

INGREDIENTS AND APPEARANCE

COMPLETE ALLERGY RELIEF 4-HOUR 
chlorpheniramine maleate tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-782
Route of Administration	ORAL

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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	TCL;242
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-782-24	2 in 1 CARTON	07/01/2015
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/30/2015

Labeler - SMART SENSE (KMART) (008965873)