Children's Tylenol ®

SPL v2

SPL

SPL Set ID 3162733b-9382-39f1-e063-6294a90ac420

Route

ORAL

Published

Effective Date 2025-04-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Sodium Citrate Sucrose Xanthan Gum Microcrystalline Cellulose Potassium Sorbate Sucralose Carboxymethylcellulose Sodium, Unspecified Anhydrous Citric Acid Glycerin Sorbitol Solution Sodium Benzoate Water

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-04-28

Description

Drug Facts

Purpose

Purpose Pain reliever/fever reducer

Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

Uses temporarily:

■ reduces fever

■ relieves minor aches and pains due to:

-the common cold

-flu

-headache

-sore throat

-toothache

Section 34088-5

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.

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

Section 51945-4

NDC 50580-139-04

NEW

Children's TYLENOL ^®

Acetaminophen (160 mg per 5 mL)

Oral Suspension

Pain Reliever-Fever Reducer

Pain+Fever

Ages 2-11 Years

DYE-FREE

Free Of:

• Dyes

• Alcohol

• Ibuprofen

• Aspirin

• Parabens

• High Fructose Corn Syrup

• Artificial Flavoring

Natural Apple

Flavor with Other

Natural Flavors

4 fl oz (120 mL) 160 mg per 5 mL

Section 53413-1

Questions or comments? call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

Directions

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 squeeze 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)*
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL
36-47 lbs	4-5 years	7.5 mL
48-59 lbs	6-8 years	10 mL
60-71 lbs	9-10 years	12.5 mL
72-95 lbs	11 years	15 mL

* or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

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

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.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Active Ingredient

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Other Information

Other information

■ each 5 mL contains: potassium 5 mg

■ store between 20-25°C (68-77°F)

■ do not use if carton is opened. Do not use if bottle wrap imprinted with “TYLENOL” is broken or missing

Inactive Ingredients

anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sodium benzoate, sodium citrate,sorbitol solution, sucralose, sucrose, xanthan gum

Structured Label Content

Uses

Uses temporarily:

■ reduces fever

■ relieves minor aches and pains due to:

-the common cold

-flu

-headache

-sore throat

-toothache

Section 34088-5 (34088-5)

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)

Section 51945-4 (51945-4)

NDC 50580-139-04

NEW

Children's TYLENOL ^®

Acetaminophen (160 mg per 5 mL)

Oral Suspension

Pain Reliever-Fever Reducer

Pain+Fever

Ages 2-11 Years

DYE-FREE

Free Of:

• Dyes

• Alcohol

• Ibuprofen

• Aspirin

• Parabens

• High Fructose Corn Syrup

• Artificial Flavoring

Natural Apple

Flavor with Other

Natural Flavors

4 fl oz (120 mL) 160 mg per 5 mL

Section 53413-1 (53413-1)

Questions or comments? call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

Purpose

Purpose

Pain reliever/fever reducer

Directions

Weight (lb)	Age (yr)	Dose (mL)*
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL
36-47 lbs	4-5 years	7.5 mL
48-59 lbs	6-8 years	10 mL
60-71 lbs	9-10 years	12.5 mL
72-95 lbs	11 years	15 mL

* or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Liver Warning (Liver warning)

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.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Active Ingredient (Active ingredient)

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Other Information (Other information)

Other information

■ each 5 mL contains: potassium 5 mg

■ store between 20-25°C (68-77°F)

■ do not use if carton is opened. Do not use if bottle wrap imprinted with “TYLENOL” is broken or missing

Inactive Ingredients (Inactive ingredients)

Advanced Ingredient Data

[{"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL SOLUTION", "unii": "8KW3E207O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Uses temporarily: ■ reduces fever ■ relieves minor aches and pains due to: -the common cold -flu -headache -sore throat -toothache", "34088-5": "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.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "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.", "50567-7": "When using this product do not exceed recommended dose (see overdose warning)", "50568-5": "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if your child has liver disease", "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", "51945-4": "NDC 50580-139-04 NEW Children's TYLENOL ® Acetaminophen (160 mg per 5 mL) Oral Suspension Pain Reliever-Fever Reducer Pain+Fever Ages 2-11 Years DYE-FREE Free Of: • Dyes • Alcohol • Ibuprofen • Aspirin • Parabens • High Fructose Corn Syrup • Artificial Flavoring Natural Apple Flavor with Other Natural Flavors 4 fl oz (120 mL) 160 mg per 5 mL", "53413-1": "Questions or comments? call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)", "Purpose": "Purpose Pain reliever/fever reducer", "Directions": "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 squeeze 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)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL * or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.", "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 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. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "Active ingredient": "Active ingredient (in each 5 mL) Acetaminophen 160 mg", "Other information": "Other information ■ each 5 mL contains: potassium 5 mg ■ store between 20-25°C (68-77°F) ■ do not use if carton is opened. Do not use if bottle wrap imprinted with “TYLENOL” is broken or missing", "Inactive ingredients": "anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sodium benzoate, sodium citrate,sorbitol solution, sucralose, sucrose, xanthan gum"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:12.283821 · Updated: 2026-03-14T23:08:50.768383