pain reliever

pain reliever
SPL v4
SPL
SPL Set ID 9d22bedb-9fb3-8421-e053-2a95a90acf4a
Route
oral
Published
Effective Date 2020-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
polyethylene glycol, unspecified stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: G551 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-01-24

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg


Medication Information

Warnings

This product contains acetaminophen. Severe liver damage may occur if you take Liver warning:

acetaminophen may cause severe skin reactions. Allergy alert:

Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

  • 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
  • skin reddening
  • blisters
  • rash
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

Directions
  • (see overdose warning) do not take more than directed
  • 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 take for more than 10 days unless directed by a doctor adults and children 12 years and over:
  • ask a doctor children under 12 years:
Other Information
  • store between 20º to 25ºC (68º to 77º F)
Inactive Ingredients

hydroxypropyl methyl cellulose, pregelatinized starch, povidone k-30, polyethylene glycol, stearic acid, sodium starch glycolate.

Description

Acetaminophen 500 mg

Questions?

call toll-free 1-800-935-6737

Do Not Use
  • with any other drugs 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
Package Labeling:

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.

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 children even if you do not notice any signs or symptoms. Overdose warning:

Active Ingredient (in Each Caplet)

Acetaminophen 500 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

Warnings

This product contains acetaminophen. Severe liver damage may occur if you take Liver warning:

acetaminophen may cause severe skin reactions. Allergy alert:

Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

  • 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
  • skin reddening
  • blisters
  • rash
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

Directions
  • (see overdose warning) do not take more than directed
  • 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 take for more than 10 days unless directed by a doctor adults and children 12 years and over:
  • ask a doctor children under 12 years:
Other Information (Other information)
  • store between 20º to 25ºC (68º to 77º F)
Inactive Ingredients (Inactive ingredients)

hydroxypropyl methyl cellulose, pregelatinized starch, povidone k-30, polyethylene glycol, stearic acid, sodium starch glycolate.

Questions?

call toll-free 1-800-935-6737

Do Not Use (Do not use)
  • with any other drugs 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
Package Labeling:

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.)

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 children even if you do not notice any signs or symptoms. Overdose warning:

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

Acetaminophen 500 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

All Sections (JSON)