ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each gelcap)

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 gelcaps (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

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

• if you are allergic to acetaminophen or any of the inactive ingredients in 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.

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  
• adults and children 12 years and over
  • take 2 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor
• children under 12 years: ask a doctor

Other information

• store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number
• avoid high humidity

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

1-888-287-1915

Principal Display Panel

NDC: 49035-519-08

equate™

Compare to
Extra Strength
Tylenol® Rapid
Release Gels
Active
Ingredient*

Extra Strength
Acetaminophen

Pain Reliever/
Fever Reducer

For Adults

Rapid Release

500 mg EACH

24 GELCAPS

Actual Size

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING

Satisfaction guaranteed - Or we'll
replace it or give you your money back.
For questions or comments or to
report an undesired reaction or side
effect, please call 1-888-287-1915.

Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716

*This product is not manufactured or
distributed by McNeil Consumer
Healthcare, owner of the registered
trademark Extra Strength Tylenol®
Rapid Release Gels.  
50844    REV0615K51908

Equate 44-519

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-519
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
STARCH, CORN (UNII: O8232NY3SJ)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	RED, BLUE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	L;5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-519-08	1 in 1 CARTON	05/10/2004	12/09/2022
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49035-519-12	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2004	12/09/2022
3	NDC: 49035-519-20	225 in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2004	12/09/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	05/10/2004	12/09/2022

Labeler - Wal-Mart Stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(49035-519)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(49035-519) , PACK(49035-519)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(49035-519)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(49035-519)