Walgreens 44-572

Walgreens 44-572
SPL v19
SPL
SPL Set ID f13fb7e9-50ea-4e2c-a442-38b1b5b315d7
Route
ORAL
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (65 mg)
Inactive Ingredients
Ammonia Croscarmellose Sodium Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Propylene Glycol Shellac Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L;2 Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-02-09 Until 2018-07-08

Description

Acetaminophen 500 mg Caffeine 65 mg

Purpose

Pain reliever Pain reliever aid


Medication Information

Purpose

Pain reliever

Pain reliever aid

Description

Acetaminophen 500 mg Caffeine 65 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches 
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.

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. 

Directions
  • do not take more than directed

  • adults and children 12 years and over: take 2 gelcaps every 6 hours. Do not take more than 6 gelcaps in 24 hours.
  • 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.

Other Information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number 
Inactive Ingredients

 ammonium hydroxide, croscarmellose sodium, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silicon dioxide, simethicone, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

Walgreens

Compare to the active ingredients

in Excedrin® Tension Headache††

• WALGREENS •

PHARMACIST RECOMMENDED

NDC 0363-0572-31

Tension

Headache

Relief

ACETAMINOPHEN / PAIN RELIEVER

CAFFEINE / PAIN RELIEVER AID

ASPIRIN FREE    

80 GELCAPS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†Our pharmacists recommend the Walgreens brand. We invite you

to compare to national brands.

††This product is not manufactured or distributed by Haleon CH SARL,

owner of the registered trademark Excedrin® Tension Headache

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

Walgreens

100% SATISFACTION

          
GUARANTEED

walgreens.com      ©2021 Walgreen Co.

50844    ORG032457231

Walgreens 44-572
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
  • redness or swelling is present
  • any new symptoms appear
If Pregnant Or Breast Feeding,

ask a health professional before use. 

Keep Out of Reach of Children.

In case of 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. 

Active Ingredients (in Each Gelcap)

Acetaminophen 500 mg

Caffeine 65 mg

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.


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches 
Purpose

Pain reliever

Pain reliever aid

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.

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. 

Directions
  • do not take more than directed

  • adults and children 12 years and over: take 2 gelcaps every 6 hours. Do not take more than 6 gelcaps in 24 hours.
  • 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.

Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number 
Inactive Ingredients (Inactive ingredients)

 ammonium hydroxide, croscarmellose sodium, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silicon dioxide, simethicone, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

Walgreens

Compare to the active ingredients

in Excedrin® Tension Headache††

• WALGREENS •

PHARMACIST RECOMMENDED

NDC 0363-0572-31

Tension

Headache

Relief

ACETAMINOPHEN / PAIN RELIEVER

CAFFEINE / PAIN RELIEVER AID

ASPIRIN FREE    

80 GELCAPS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†Our pharmacists recommend the Walgreens brand. We invite you

to compare to national brands.

††This product is not manufactured or distributed by Haleon CH SARL,

owner of the registered trademark Excedrin® Tension Headache

DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015

Walgreens

100% SATISFACTION

          
GUARANTEED

walgreens.com      ©2021 Walgreen Co.

50844    ORG032457231

Walgreens 44-572
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
  • redness or swelling is present
  • any new symptoms appear
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.)

In case of 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. 

Active Ingredients (in Each Gelcap) (Active ingredients (in each gelcap))

Acetaminophen 500 mg

Caffeine 65 mg

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.


Advanced Ingredient Data


Raw Label Data

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