PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet, film coated

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

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 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 of 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 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets 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

Inactive ingredients

caster oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

 1-800-426-9391

Principal Display Panel

RITE
AID®
PHARMACY

*Compare to the active ingredient in Extra Strength Tylenol® Caplets

EXTRA STRENGTH
pain relief
acetaminophen

acetaminophen 500 mg
pain reliever fever reducer

contains no aspirin

ACTUAL SIZE

2 CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OF IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol® Caplets.
50844    ORG061717524

DISTRIBUTED BY:
RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011

SATISFACTION GUARANTEE
RITE AID®

IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

Rite Aid 44-175

INGREDIENTS AND APPEARANCE

PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0812
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
CASTOR OIL (UNII: D5340Y2I9G)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;175
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0812-3	1 in 1 CARTON	04/02/1993
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 11822-0812-5	1 in 1 CARTON	04/02/1993
2		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 11822-0812-6	1 in 1 CARTON	04/02/1993
3		16 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 11822-0812-1	1 in 1 CARTON	04/02/1993
4		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 11822-0812-2	1 in 1 CARTON	04/02/1993
5		12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC: 11822-0812-8	1 in 1 CARTON	04/02/1993
6		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7	NDC: 11822-0812-4	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/02/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	04/02/1993

Labeler - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(11822-0812)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(11822-0812) , PACK(11822-0812)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(11822-0812)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(11822-0812)