ACETAMINOPHEN EXTRA STRENGTH - acetaminophen tablet, coated
Western Family Foods Inc

Western Family Acetaminophen Drug Facts

Active ingredient (in each geltab)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

•: temporarily relieves minor aches and pains due to:
•: headache
•: the common cold
•: backache
•: minor pain of arthritis
•: toothache
•: muscular aches
•: premenstrual and menstrual cramps
•: temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 geltabs (3,000 mg) in 24 hours. Severe liver damage may occur if you take

•: more than 4,000 mg of acetaminophen in 24 hours
•: with other drugs containing acetaminophen
•: 3 or more alcoholic drinks every day 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 reaction to this product of any of its ingredients

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

•: pain gets worse or lasts for more than 10 days
•: fever gets worse or lasts for more than 3 days
•: new symptoms occur
•: redness or swelling is present

These could be signs of a serious condition.

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

Directions

•: do not take more than directed (see Liver warning)

adults and children 12 years and over	• take 2 geltabs every 6 hours while symptoms last • do not take more than 6 geltabs in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Other information

•: store at 20–25ºC (68-77ºF)

Inactive ingredients

corn starch*,croscarmellose sodium*, D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, purified water, sodium starch glycolate*, stearic acid, titanium dioxide *May contain one or more of these ingredients

Principal Display Panel

See New Warnings & Directions

EXTRA STRENGTH

GELTABS

Acetaminophen

ASPIRIN FREE

PAIN RELIEVER / FEVER REDUCER

Gluten Free

COMPARE TO TYLENOL® active ingredient

500 mg each

ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	55312-187
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
EDETATE DISODIUM
FD&C RED NO. 40
GELATIN
GLYCERIN
HYPROMELLOSES
POLYETHYLENE GLYCOLS
POVIDONES
WATER
STEARIC ACID
TITANIUM DIOXIDE

Product Characteristics
Color	YELLOW, RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	L187
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	55312-187-78	1 In 1 CARTON	contains a BOTTLE
1		100 In 1 BOTTLE	This package is contained within the CARTON (55312-187-78)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/13/1994

Labeler - Western Family Foods Inc (192166072)

Revised: 03/2013Western Family Foods Inc