PAIN RELIEVER EXTRA STRENGTH- acetaminophen tablet

Pain Reliever by

Drug Labeling and Warnings

Pain Reliever by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • backache
  • toothache
  • premenstrual and menstrual cramps
  • the common cold
  • minor pain of arthritis
  • muscular aches
• temporarily reduces fever 

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (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

• 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 are allergic to acetaminophen or any of the inactive ingredients in this product

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 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets 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 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

Inactive ingredients

corn starch, povidone, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS Health™

Compare to the active ingredient in Extra Strength Tylenol®*

Tablets
NDC: 59779-101-12

EXTRA STRENGTH
Pain Relief
ACETAMINOPHEN, 500 mg
Pain reliever, Fever reducer
Aspirin free

100 TABLETS  Actual Size

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

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

50844  ORG061514812

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy
CVS.com®   1-800-SHOP CVS

V-11112

CVS® Quality
Money Back Guarantee

CVS Health 44-148

INGREDIENTS AND APPEARANCE

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-101
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
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	44;148
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-101-11	1 in 1 CARTON	01/21/1993	10/20/2019
1		60 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 59779-101-12	1 in 1 CARTON	01/21/1993
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 59779-101-03	10 in 1 VIAL, PLASTIC; Type 0: Not a Combination Product	01/21/1993	07/08/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/21/1993

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(59779-101)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(59779-101)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(59779-101)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(59779-101)