PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by DOLGENCORP, LLC, 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
  • muscular aches
  • toothache
  • minor pain of arthritis
  • 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

• 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)
• avoid high humidity
• use by expiration date on package

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

Principal Display Panel

Since 1903
Rexall®

EXTRA STRENGTH

Pain Relief
Acetaminophen 500 mg

Pain Reliever
Fever reducer
Contains no
  aspirin

120
Rapid Release
Gelcaps

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

50844      REV0417D51932

Visit us at: Rexall.com or call 1-866-4-REXALL

MANUFACTURED FOR DOLGENCORP, LLC
100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA
Since 1903 Rexall® is a registered trademark of Rexall Sundown, Inc.

Rexall 44-519

INGREDIENTS AND APPEARANCE

PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-812
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)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
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: 55910-812-08	1 in 1 CARTON	05/10/2004
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 55910-812-32	120 in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2004

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

Labeler - DOLGENCORP, LLC (068331990)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(55910-812)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(55910-812) , PACK(55910-812)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(55910-812)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(55910-812)