ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet
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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Western Family Acetaminophen Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

•: temporarily relieves minor aches and pains due to:
•: the common cold
•: headache
•: 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 4,000 mg of acetaminophen in 24 hours
•: with other drugs containing acetaminophen
•: 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

•: skin reddening
•: blisters
•: rash

If a skin reaction occurs, stop use and seek medical help right away.

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 or 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 more than 10 days
•: fever gets worse or lasts 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.

Overdose warning: 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 overdose warning)

adults and children 12 years and over	• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets 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 20-25°C (68-77°F)

Inactive ingredients

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

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BUY ONE GET ONE FREE

TWO 100 COUNT BOTTLES INSIDE

TOTAL = 200 CAPLETS

EXTRA STRENGTH

ASPIRIN FREE CAPLETS

Acetaminophen

PAIN RELIEVER/FEVER REDUCER

FOR ADULTS

Gluten Free

COMPARE TO TYLENOL® active ingredient

Actual Size

100 CAPLETS – 500 mg EACH

ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-484
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	L484
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55312-484-71	1 in 1 CARTON	03/14/2008	01/12/2017
1		50 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:55312-484-78	1 in 1 CARTON	03/14/2008	09/18/2018
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:55312-484-90	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2008	11/27/2017
4	NDC:55312-484-62	1 in 1 CARTON	03/14/2008	09/12/2018
4		24 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:55312-484-52	10 in 1 VIAL; Type 0: Not a Combination Product	03/14/2008	03/01/2014
6	NDC:55312-484-02	550 in 1 BOTTLE; Type 0: Not a Combination Product	03/14/2008	04/30/2016
7	NDC:55312-484-82	2 in 1 CARTON	03/14/2008	05/25/2017
7		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/14/2008	09/18/2018

Labeler - Western Family Foods Inc (192166072)

Revised: 11/2020

Document Id: 42e5ea85-2b0e-4ab0-9c8c-962433616d5b

Set id: 09a2bf1e-8518-4dca-87a0-bf41e5fcedb2

Version: 7

Effective Time: 20201130

Western Family Foods Inc