Extra Strength Pain Relief Acetaminophen 500 Mg

Extra Strength Pain Relief Acetaminophen 500 Mg
SPL v1
SPL
SPL Set ID e817bc4a-43ef-4126-b903-aabd1390cd0c
Route
ORAL
Published
Effective Date 2025-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Povidone K30 Stearic Acid Microcrystalline Cellulose Magnesium Stearate Hypromellose, Unspecified Polyethylene Glycol 400 Titanium Dioxide Talc

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-09

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Overdose warning:  In case of overdose, get medical help or contact a Poison Control (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.

Section 50566-9

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
  • new symptoms occur

These could be signs of a serious condition.

Section 50568-5

Ask a doctor/pharmacist before use if you are

  • taking the blood thinning drug warfarin
Section 50569-3

Ask a doctor before use if you have

  • liver disease
Section 50570-1

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 ingredient in this product.
Section 53414-9

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

Section 60561-8

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.
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
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
Other Information
  • store at 20º - 25ºC (68º -77ºF)
Inactive Ingredients

Pregelatinzed starch, Polyvinyl pyrrolidone, stearic acid powder, microcrystalline cellulose, magnesium stearate, Hypromellose-5, Hypromellose-15, polyethlene glycol 400, titanium dioxide, talc

Questions Or Comments?

Call 1 (732) 994-2808 or email [email protected]

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

Ndc 72090 038 01 (500ct Hdpe Bottle)

Ndc 72090 038 02 (300ct Hdpe Bottle)


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Overdose warning:  In case of overdose, get medical help or contact a Poison Control (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.

Section 50566-9 (50566-9)

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
  • new symptoms occur

These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor/pharmacist before use if you are

  • taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
Section 50570-1 (50570-1)

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 ingredient in this product.
Section 53414-9 (53414-9)

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

Section 60561-8 (60561-8)

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.
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
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
Other Information (Other information)
  • store at 20º - 25ºC (68º -77ºF)
Inactive Ingredients (Inactive ingredients)

Pregelatinzed starch, Polyvinyl pyrrolidone, stearic acid powder, microcrystalline cellulose, magnesium stearate, Hypromellose-5, Hypromellose-15, polyethlene glycol 400, titanium dioxide, talc

Questions Or Comments? (Questions or comments?)

Call 1 (732) 994-2808 or email [email protected]

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 500 mg

Ndc 72090 038 01 (500ct Hdpe Bottle) (NDC 72090-038-01 (500ct HDPE Bottle))

Ndc 72090 038 02 (300ct Hdpe Bottle) (NDC 72090-038-02 (300ct HDPE Bottle))


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)