KGS ALLERGY SOOTHING- acetaminophen chlorpheniramine maleate capsule, delayed release pellets

KGS by

Drug Labeling and Warnings

KGS by is a Otc medication manufactured, distributed, or labeled by Kingsway, Guangzhou Baiyunshan Guanghua Pharmacy Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Acetaminophen 250 mg
Chlorpheniramine Maleate 2 mg

Purpose

Pain reliever

Antihistamine

Uses

■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

Warnings

Liver warningThis 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.

Do not use

■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.

Directions

■ 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

Inactive ingredients

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

Package Label

INGREDIENTS AND APPEARANCE

KGS  ALLERGY SOOTHING
acetaminophen chlorpheniramine maleate capsule, delayed release pellets

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63922-605
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
CAFFEINE (UNII: 3G6A5W338E)
COCHINEAL (UNII: TZ8Z31B35M)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white (clear)	Score	2 pieces
Shape	CAPSULE (Capsule)	Size	20mm
Flavor		Imprint Code
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/30/2014

Labeler - Kingsway (780573205)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Baiyunshan Guanghua Pharmacy Co.,Ltd.		527226626	manufacture(63922-605)