ACETAMINOPHEN EXTRA STRENGTH- acetaminophen kit

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen 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 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

♥︎CVSHealth™

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

Caplets

EXTRA STRENGTH
ACETAMINOPHEN
Caplets 500 mg 
Pain reliever, Fever reducer

50 COATED CAPLETS +
10 CT TRAVEL VIAL

Actual Size

Actual Bottle
Size on Top Panel

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

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895
© 2020 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-11112

CVS® Quality
Money Back Guarantee

50844    ORG061717511

CVSHealth™

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

Caplets

EXTRA STRENGTH
ACETAMINOPHEN
Caplets 500 mg
Pain reliever, Fever reducer

50 COATED CAPLETS +
10 CT TRAVEL VIAL

Actual Size

Actual Bottle
Size on Top Panel

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

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895
© 2020 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-11112

CVS® Quality
Money Back Guarantee

50844    ORG061717511

CVS 44-175-11 ORG0617

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-759

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-759-11	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	01/28/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	50
Part 2	1 BOTTLE, PLASTIC	10

Part 1 of 2

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
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
CASTOR OIL (UNII: D5340Y2I9G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

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		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/28/2020

Part 2 of 2

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
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
CASTOR OIL (UNII: D5340Y2I9G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

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		10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/28/2020

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(69842-759) , PACK(69842-759)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(69842-759)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(69842-759)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(69842-759)