Extra Strength Pain Reliever

Extra Strength Pain Reliever
SPL v5
SPL
SPL Set ID ee8e0e79-4da4-101f-e053-2a95a90a30a4
Route
ORAL
Published
Effective Date 2022-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Hypromellose, Unspecified Povidone, Unspecified Sodium Starch Glycolate Type A Corn Maltodextrin Microcrystalline Cellulose Titanium Dioxide Stearic Acid Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: AZ;235 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-01-17 Until 2027-06-18

Description

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 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
Section 42229-5

*This product is not manufactured or distributed by JOHNSON & JOHNSON, INC., McNeil Consumer Healthcare Division,

distributor of Tylenol® Extra Strength.

Manufactured for:

Lil' Drug Store products, Inc.

9300 Earhart Lane SW

Cedar Rapids, IA 52404

Section 51945-4

COMPARE TO THE ACTIVE INGREDIENT IN

Tylenol® Extra Strength*

Extra Strength

Pain Reliever

Acetaminophen 500mg

Pain Reliever/Fever Reducer

actual size [pill image]

2 TABLETS PER POUCH

Directions
  • do not take more than directed (see overdose warning)
    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 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
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.

Liver Warning

This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours.

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.
Other Information
  • do not use if inner pouch or carton is open or damaged
  • store at room temperature 59-86˚F (15-30˚C)
  • see bottom panel for lot number and expiration date
Inactive Ingredients

corn starch, hypromellose, maltodextrin

may contain
, microcrystalline cellulose
, polyethylene glycol, povidone
, pregelatinized starch
, sodium starch glycolate
, stearic acid, titanium dioxide

Questions Or Comments?

call toll-free 1-800-351-2000 (M-F 8:00 AM-4:30 PM CST)

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.

Keep Out of Reach of Children

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Tablet)

Acetaminophen 500 mg

Ask A Doctor Before Use If You Are

taking the blood thinning drug warfarin

Ask A Doctor Before Use If You Have

liver disease


Structured Label Content

Uses (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
Section 42229-5 (42229-5)

*This product is not manufactured or distributed by JOHNSON & JOHNSON, INC., McNeil Consumer Healthcare Division,

distributor of Tylenol® Extra Strength.

Manufactured for:

Lil' Drug Store products, Inc.

9300 Earhart Lane SW

Cedar Rapids, IA 52404

Section 51945-4 (51945-4)

COMPARE TO THE ACTIVE INGREDIENT IN

Tylenol® Extra Strength*

Extra Strength

Pain Reliever

Acetaminophen 500mg

Pain Reliever/Fever Reducer

actual size [pill image]

2 TABLETS PER POUCH

Purpose

Pain reliever/fever reducer

Directions
  • do not take more than directed (see overdose warning)
    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 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
Allergy Alert (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.

Liver Warning (Liver warning)

This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours.

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.
Other Information
  • do not use if inner pouch or carton is open or damaged
  • store at room temperature 59-86˚F (15-30˚C)
  • see bottom panel for lot number and expiration date
Inactive Ingredients

corn starch, hypromellose, maltodextrin

may contain
, microcrystalline cellulose
, polyethylene glycol, povidone
, pregelatinized starch
, sodium starch glycolate
, stearic acid, titanium dioxide

Questions Or Comments? (Questions or Comments?)

call toll-free 1-800-351-2000 (M-F 8:00 AM-4:30 PM CST)

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.

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

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Acetaminophen 500 mg

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

taking the blood thinning drug warfarin

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

liver disease


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)