OTC Medication Information: Acetaminophen Extra Strength

ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated
CVS PHARMACY

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • headache
    • backache
    • the common cold
    • 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:

  • rash
  • skin reddening
  • blisters

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

  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur

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 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)
  • use by expiration date on package

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

TWIN PACK 2 x 10 COUNT VIALS

♥︎CVS
Health®

Compare to the active ingredient
in Extra Strength Tylenol®*

Caplets

EXTRA STRENGTH
ACETAMINOPHEN
Caplets, 500 mg
Pain reliever, Fever reducer

TAMPER EVIDENT: Use Only if This Blister is Intact

Actual Size

20 CAPLETS (2 VIALS — 10 CAPLETS EACH)

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered
trademark Extra Strength Tylenol®. 50844 REV0621C17503

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2022 CVS/pharmacy
CVS.com® 1-800-SHOP-CVS
V-11112

CVS® Quality
Money Back Guarantee

CVS 44-175
(click image for full-size original)

CVS 44-175

ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-750
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CASTOR OIL
HYPROMELLOSE, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 44;175
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-750-03 1 BOTTLE in 1 PACKAGE contains a BOTTLE
1 10 TABLET, FILM COATED in 1 BOTTLE This package is contained within the PACKAGE (69842-750-03)
2 NDC:69842-750-96 2 BOTTLE, PLASTIC in 1 PACKAGE contains a BOTTLE, PLASTIC
2 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the PACKAGE (69842-750-96)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 04/02/1993
Labeler — CVS PHARMACY (062312574)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (69842-750)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (69842-750)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (69842-750)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 manufacture (69842-750)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (69842-750)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117597853 pack (69842-750)

Revised: 09/2023 CVS PHARMACY

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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