tylenol extra strength

tylenol extra strength
SPL v5
SPL
SPL Set ID 68b0be18-198e-48c7-a7a2-e81cbcf0fbe8
Route
oral
Published
Effective Date 2018-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
carnauba wax starch, corn fd&c red no. 40 aluminum oxide hypromellose, unspecified magnesium stearate polyethylene glycol, unspecified powdered cellulose propylene glycol shellac sodium starch glycolate type a potato titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TYLENOL;500 Shape: oval Color: white Size: 19 mm Score: 1
Marketing Status
otc monograph drug active Since 2018-09-20

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. Symptoms may include: Allergy alert:

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
  • 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 between 20-25°C (68-77°F)
  • do not use if pouch is torn or damaged
Inactive Ingredients

carnauba wax*, corn starch*, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch*, polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

*contains one or more of these ingredients

Description

Acetaminophen 500 mg

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
Package Labeling:

Questions Or Comments?

call (toll-free) or (collect) 1-877-895-3665 215-273-8755

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 for 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. Symptoms may include: Allergy alert:

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
  • 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 between 20-25°C (68-77°F)
  • do not use if pouch is torn or damaged
Inactive Ingredients (Inactive ingredients)

carnauba wax*, corn starch*, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch*, polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

*contains one or more of these ingredients

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
Package Labeling:

Questions Or Comments? (Questions or comments?)

call (toll-free) or (collect) 1-877-895-3665 215-273-8755

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 for 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)