tylenol extra strength

tylenol extra strength
SPL v7
SPL
SPL Set ID ab02080a-c903-4e4a-a9f3-2b8197ed2f2b
Route
oral
Published
Effective Date 2021-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
anhydrous citric acid ethylcellulose, unspecified magnesium stearate maltodextrin sodium bicarbonate sucralose xylitol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2020-06-15

Purpose

Pain reliever/fever reducer

Description

Drug Facts


Medication Information

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)
  • tear packet and pour powder directly on tongue
    adults and children 12 years and over
    • take 2 powders every 6 hours, while symptoms last
    • do not take more than 6 powders 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
  • each powder contains: sodium 4 mg
  • store between 20-25°C (68-77°F)
  • do not use if packet is torn or damaged
Inactive Ingredients

citric acid, ethylcellulose, flavor, magnesium stearate, maltodextrin, sodium bicarbonate, sucralose, xylitol

Description

Drug Facts

Principal Display Panel

NDC 50580-209-04

Extra Strength

TYLENOL ®

FOR ADULTS

Acetaminophen

Pain Reliever-Fever Reducer

DISSOLVE PACKS

  • NO WATER NEEDED
  • DISSOLVES IN SECONDS

32 Packets*

500 mg

each packet

Berry

Flavor

*Packets of Powder

Section 42229-5

Drug Facts

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 50569-3

Ask a doctor before use if you have liver disease

Section 53414-9

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

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.

Questions Or Comments?

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

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.

Active Ingredient (in Each Powder)

Acetaminophen 500 mg


Structured Label Content

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)
  • tear packet and pour powder directly on tongue
    adults and children 12 years and over
    • take 2 powders every 6 hours, while symptoms last
    • do not take more than 6 powders 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)
  • each powder contains: sodium 4 mg
  • store between 20-25°C (68-77°F)
  • do not use if packet is torn or damaged
Inactive Ingredients (Inactive ingredients)

citric acid, ethylcellulose, flavor, magnesium stearate, maltodextrin, sodium bicarbonate, sucralose, xylitol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-209-04

Extra Strength

TYLENOL ®

FOR ADULTS

Acetaminophen

Pain Reliever-Fever Reducer

DISSOLVE PACKS

  • NO WATER NEEDED
  • DISSOLVES IN SECONDS

32 Packets*

500 mg

each packet

Berry

Flavor

*Packets of Powder

Section 42229-5 (42229-5)

Drug Facts

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 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 53414-9 (53414-9)

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

Questions Or Comments? (Questions or comments?)

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

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.

Active Ingredient (in Each Powder) (Active ingredient (in each powder))

Acetaminophen 500 mg


Advanced Ingredient Data


Raw Label Data

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