Pain Reliever

Pain Reliever
SPL v3
SPL
SPL Set ID e5fc5340-c224-e02b-e053-2a95a90a5297
Route
ORAL
Published
Effective Date 2023-08-01
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: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-01

Description

Active ingredient (in each caplet) Acetaminophen USP 500 mg

Purpose

Purpose Pain reliever/fever reducer


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each caplet) Acetaminophen USP 500 mg

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

**This product is not manufactured or distributed by JOHNSON & JOHNSON CONSUMER, INC., McNeil Consumer Healthcare Division, distributor of Tylenol® Extra Strength Caplets.

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Questions

Questions or comments?

Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Directions

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
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. 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
Overdose Warning

Overdose warning: In case of overdose, get 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.

Active Ingredient

Active ingredient (in each caplet)

Acetaminophen USP 500 mg

Other Information

Other information

  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients

Inactive ingredients povidone, pregelatinized starch (maize), stearic acid

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.

Extra Strength Pain Reliever, Casey's 4good, 50ct Pdp/package

EXTRA STRENGTH

Pain Reliever

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Compare to the

active ingredient

in Tylenol® Extra

Strength*

[caplet image]

actual

size

[ Casey's 4good logo TM]

50 CAPLETS

Extra Strength Pain Reliever, Lil' Drug Store, 50ct Pdp/package

[caduceus]

Compare to the Active

Ingredient in Tylenol®

Extra Strength Caplets**

Extra Strength

Pain Reliever

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

[caplet image]

ACTUAL SIZE

50Caplets

[Lil' Drug Store logo]


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 CONSUMER, INC., McNeil Consumer Healthcare Division, distributor of Tylenol® Extra Strength Caplets.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Purpose

Pain reliever/fever reducer

Questions

Questions or comments?

Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Directions

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
Do Not Use (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)

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)

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
Overdose Warning (Overdose warning)

Overdose warning: In case of overdose, get 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.

Active Ingredient (Active ingredient)

Active ingredient (in each caplet)

Acetaminophen USP 500 mg

Other Information (Other information)

Other information

  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

Inactive ingredients povidone, pregelatinized starch (maize), stearic acid

Stop Use and Ask A Doctor If (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.

Extra Strength Pain Reliever, Casey's 4good, 50ct Pdp/package (Extra Strength Pain Reliever, Casey's 4good, 50ct PDP/Package)

EXTRA STRENGTH

Pain Reliever

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Compare to the

active ingredient

in Tylenol® Extra

Strength*

[caplet image]

actual

size

[ Casey's 4good logo TM]

50 CAPLETS

Extra Strength Pain Reliever, Lil' Drug Store, 50ct Pdp/package (Extra Strength Pain Reliever, Lil' Drug Store, 50ct PDP/Package)

[caduceus]

Compare to the Active

Ingredient in Tylenol®

Extra Strength Caplets**

Extra Strength

Pain Reliever

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

[caplet image]

ACTUAL SIZE

50Caplets

[Lil' Drug Store logo]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)