children's tylenol ®

children's tylenol ®
SPL v7
SPL
SPL Set ID ce0a1fbc-7345-462b-b0da-c7149bdc288c
Route
oral
Published
Effective Date 2020-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (160 mg)
Inactive Ingredients
anhydrous citric acid d&c red no. 33 fd&c blue no. 1 glycerin high fructose corn syrup microcrystalline cellulose carboxymethylcellulose sodium, unspecified form water sodium benzoate sorbitol solution sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
otc monograph drug active Since 2017-01-16
Purpose

Pain reliever/fever reducer

Description

Drug Facts

Medication Information

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
Purpose

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and pour your child's dose into the dosing cup
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (mL)
or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL
36-47 4-5 years 7.5 mL
48-59 6-8 years 10 mL
60-71 9-10 years 12.5 mL
72-95 11 years 15 mL
Other Information
  • each 5 mL contains: sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton tape or bottle wrap imprinted with "TYLENOL" is broken or missing
Inactive Ingredients

anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Description

Drug Facts

Principal Display Panel

NDC 50580-579-02

Children's

TYLENOL ®

Acetaminophen (160 mg per 5 mL)

Oral Suspension

Pain Reliever-Fever Reducer

Pain+Fever

Ages 2-11 Years

For In-Patient Use Only

Hospital/Government

Not For Retail Sale

Alcohol Free

Ibuprofen Free

Aspirin Free

No Parabens

4 fl oz (120 mL)

160 mg per 5 mL

Grape

Flavor

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • pain gets worse or lasts more than 5 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.

Section 50567-7

When using this product do not exceed recommended dose (see overdose warning)

Section 50568-5

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if your child has 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product
Liver Warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
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 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

Structured Label Content

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
Purpose

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and pour your child's dose into the dosing cup
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (mL)
or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL
36-47 4-5 years 7.5 mL
48-59 6-8 years 10 mL
60-71 9-10 years 12.5 mL
72-95 11 years 15 mL
Other Information (Other information)
  • each 5 mL contains: sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton tape or bottle wrap imprinted with "TYLENOL" is broken or missing
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-579-02

Children's

TYLENOL ®

Acetaminophen (160 mg per 5 mL)

Oral Suspension

Pain Reliever-Fever Reducer

Pain+Fever

Ages 2-11 Years

For In-Patient Use Only

Hospital/Government

Not For Retail Sale

Alcohol Free

Ibuprofen Free

Aspirin Free

No Parabens

4 fl oz (120 mL)

160 mg per 5 mL

Grape

Flavor

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • pain gets worse or lasts more than 5 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.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose (see overdose warning)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if your child has 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 your child is 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 your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
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 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Acetaminophen 160 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:20.981004 · Updated: 2026-03-14T23:05:00.698531