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

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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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. Severe liver damage may occur if you take

more than 8 geltabs in 24 hours, which is the maximum daily amount
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.

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 as needed do not take more than 8 geltabs in 24 hours
children under 12 years	do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

store at 20º–25ºC (68º-77ºF)

Inactive ingredients

croscarmellose sodium, D&C yellow no. 10, edetate disodium, edible ink, FD&C red no. 40, gelatin, glycerin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Principal Display Panel

See New Warnings Information

EXTRA STRENGTH

GELTABS

Acetaminophen

ASPIRIN FREE

PAIN RELIEVER / FEVER REDUCER

Gluten Free

COMPARE TO TYLENOL® active ingredient

500 mg each

Acetaminophen Carton Image 1

Acetaminophen Carton Image 2

ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: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
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
EDETATE DISODIUM
FD&C RED NO. 40
GELATIN
GLYCERIN
HYPROMELLOSES
POLYETHYLENE GLYCOLS
POVIDONE
STEARIC ACID
TITANIUM DIOXIDE

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

Packaging
#	Item Code	Package Description
1	NDC:55312-187-78	1 in 1 CARTON
1		100 in 1 BOTTLE

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: 03/2010

Document Id: acc45b4a-0cee-40ff-81b7-6bb1f66a2d2b

Set id: acc45b4a-0cee-40ff-81b7-6bb1f66a2d2b

Version: 1

Effective Time: 20100324

Western Family Foods Inc