SPL v4
SPL
SPL Set ID cc939a7c-ce56-5dd6-e053-2995a90aa8af
Route
ORAL
Published
Effective Date 2023-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Povidone K30 Starch, Corn Palmitostearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: N79 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-02
Description

Active ingredient (in each caplet) Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each caplet) Acetaminophen USP 500 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • 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.

Directions
  • do not take more than directed (see overdose warning)
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 use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor



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
Drug Facts

Active ingredient (in each caplet)



Acetaminophen USP 500 mg

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened, or printed foil seal under cap is torn or missing.
Inactive Ingredients

povidone, pregelatinized starch (maize), stearic acid.

Questions Or Comments?

1-855-274-4122



DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

Walgreens.com ©2021 Walgreen Co.



MADE IN INDIA



Code: TS/DRUGS/16/2014

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.

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Package Label Principal Display Panel 500 Mg (225 Caplets Bottle)

NDC 0363-9947-35



Walgreens



Compare to the active ingredient in

Tylenol ®Extra Strength Caplets #



SEE NEW WARNINGS INFORMATION & DIRECTIONS



FOR ADULTS

Pain

Reliever

ACETAMINOPHEN 500 mg

PAIN RELIEVER / FEVER REDUCER



Extra Strength



225CAPLETS

       500 mg EACH





Package Label Principal Display Panel 500 Mg (225 Caplets Carton Label)

NDC 0363-9947-35



Walgreens



Compare to the active ingredient in

Tylenol ® Extra strength Caplets #



SEE NEW WARNINGS INFORMATION & DIRECTIONS



FOR ADULTS

Pain

Reliever

ACETAMINOPHEN 500MG

PAIN RELIEVER / FEVER REDUCER



Extra Strength

225

CAPLETS

500 mg EACH 





Structured Label Content

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

Pain reliever/fever reducer

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.

Directions
  • do not take more than directed (see overdose warning)
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 use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor



Do Not Use (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
Drug Facts

Active ingredient (in each caplet)



Acetaminophen USP 500 mg

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened, or printed foil seal under cap is torn or missing.
Inactive Ingredients (Inactive ingredients)

povidone, pregelatinized starch (maize), stearic acid.

Questions Or Comments? (Questions or comments?)

1-855-274-4122



DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

Walgreens.com ©2021 Walgreen Co.



MADE IN INDIA



Code: TS/DRUGS/16/2014

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Package Label Principal Display Panel 500 Mg (225 Caplets Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (225 Caplets Bottle))

NDC 0363-9947-35



Walgreens



Compare to the active ingredient in

Tylenol ®Extra Strength Caplets #



SEE NEW WARNINGS INFORMATION & DIRECTIONS



FOR ADULTS

Pain

Reliever

ACETAMINOPHEN 500 mg

PAIN RELIEVER / FEVER REDUCER



Extra Strength



225CAPLETS

       500 mg EACH





Package Label Principal Display Panel 500 Mg (225 Caplets Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (225 Caplets Carton Label))

NDC 0363-9947-35



Walgreens



Compare to the active ingredient in

Tylenol ® Extra strength Caplets #



SEE NEW WARNINGS INFORMATION & DIRECTIONS



FOR ADULTS

Pain

Reliever

ACETAMINOPHEN 500MG

PAIN RELIEVER / FEVER REDUCER



Extra Strength

225

CAPLETS

500 mg EACH 





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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:27.763364 · Updated: 2026-03-14T23:02:00.533418