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KGS

Kingsway

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each capsule)

Acetaminophen 250 mg
Chlorpheniramine Maleate 2 mg

Purpose

Pain reliever

Antihistamine

■temporarily relieves these symptoms of hay fever and other upper respiratory allergies: 

■runny nose and sneezing ■itchy, watery eyes

■temporarily relieves these additional symptoms of hay fever or other respiratory allergies:

■headache ■minor aches and pains

Liver warning This product contains acetaminophen. The maximum daily dose of this product is 12 capsules in 24 hours. Severe liver damage many occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■with other drugs containing acetaminophen ■3 or more alcoholic drinks daily while using this product.

■with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.

■if you have ever had an allergic reactionto this product or any of its ingredients

■to make a child sleepy

Ask a doctor before use if you have

■ liver disease ■ trouble urinating due to an enlarged prostate gland

■ a breathing problem such as emphysema or chronic bronchitis ■ Glaucoma

Ask a doctor or pharmacist if you are

■ taking the blood thinner drug, warfarin

■ taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage

■ drowsiness may occur ■alcohol, sedatives and tranquilizers may increase drowsiness

■ avoid alcoholic drinks ■be careful when driving a motor vehicle or operating machinery

■ excitability may occur, especially in children

Stop use and ask a doctor if

■ nervousness, dizziness, or sleepleessness occur ■ pain gets worse or lasts more than 7 days

■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur

This could be signs of a serious condition

If pregnant or breast-feeding

ask a health professional before

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). Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.

■ do not take more than directed (see Liver warning)

adults and children 12 years of age and over

■ take 2 caplets every 4 hours. ■swallow whole-do not crush, chew dissolve 

■ do not take more than 12 capsules in 24 hours. ■ children under 12 years ask a doctor

Caffeine, Carmine, Corn Starch, FDC Yellow 5, FDC Blue 1,hydroxy methylcellulose, Sugar

Package Label

KGS

KGS

Acetaminophen Chlorpheniramine Maleate CAPSULE, DELAYED RELEASE PELLETS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63922-605
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 250 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg

Inactive Ingredients

Ingredient Name Strength
CAFFEINE
COCHINEAL
STARCH, CORN
FD&C YELLOW NO. 5
FD&C BLUE NO. 1
HYDROXYMETHYL CELLULOSE
SUCROSE

Product Characteristics

Color Size Shape
white (clear) 20 mm CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63922-605-12 12 in 1 BLISTER PACK
2 NDC:63922-605-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-01-30


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Be sure to consult your doctor before taking any medication!
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