ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated

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 tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  
  • toothache
  • headache
    
  • the common cold
  • backache
    
  • muscular aches
    
  • 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 in 24 hours, which is the maximum daily amount
  
• 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:

• blisters
• rash
• skin reddening
  

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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• use by expiration date on package
  

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

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CVS
Health™

Compare to the active ingredient
in Extra Strength Tylenol® *

Easy to Swallow Tablets

NDC: 69842-531-29

EXTRA STRENGTH
Acetaminophen
Tablets, 500 mg

Pain reliever, Fever reducer

Aspirin free
Sweet coating

150 FILM COATED
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®.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy CVS.com®
1-800-SHOP CVS V-11112

CVS® Quality
Money Back Guarantee

50844        ORG081653129

CVS 44-531

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-531
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;531
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-531-29	150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/11/2005	08/24/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	12/11/2005	08/24/2021

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(69842-531)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(69842-531)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(69842-531)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(69842-531)