Tylenol For Children Plus Adults

SPL v5

SPL

SPL Set ID 5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42

Route

ORAL

Published

Effective Date 2021-04-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-07-01

Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

temporarily:
- reduces fever
- relieves minor aches and pains due to:
  - the common cold
  - flu
  - headache
  - sore throat
  - toothache
  - muscular aches
  - backache
  - minor pain of arthritis
  - premenstrual and menstrual cramps

Section 42229-5

Drug Facts

Section 43683-2

dsdsds

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 10 days in adults

■ pain gets worse or lasts more than 5 days in children under 12 years

■ 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 the user is taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if the user

■ has liver disease

■ is a child with pain of arthritis

Section 53414-9

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

Directions

■ do not give more than directed (see overdose warning)

■ shake well before using

■ mL = milliliter

■ Children 2 years to under 12 years:

■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.

■ remove the child protective cap and squeeze the dose into the dosing cup

■ repeat dose every 4 hours while symptoms last

■ do not take more than 5 times in 24 hours unless directed by a doctor

■ do not take for more than 5 days unless directed by a doctor

Weight (lb)	Age (years)	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

■ Adults and children 12 years and over:

■ take 20 mL (2 x 10 mL) every 4 hours while symptoms last. For adult dosing,the dosing cup needs to be filled to 10 mL line twice.

■ do not take more than 5 doses (100 mL) in 24 hours unless directed by a doctor

■ do not take for more than 10 days unless directed by a doctor

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

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

■ adult takes more than 4,000 mg of acetaminophen in 24 hours

■ child takes more than 5 doses in 24 hours, which is the maximum daily amount

■ taken with other drugs containing acetaminophen

■ adult has 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.

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

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.

Inactive Ingredients

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

Questions Or Comments?

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

Principal Display Panel

NDC 50580-177-08

Same as Children's TYLENOL ^®

with adult dosing

TYLENOL ^®

FOR CHILDREN

+ ADULTS FAMILY

Acetaminophen (160 mg per 5 mL)

Oral Suspension

Pain Reliever-Fever Reducer

DYE-FREE

Pain+Fever

Ages 2 Years – Adult

FREE OF:

Dyes

Alcohol

Ibuprofen

Aspirin

Parabens

High Fructose

Corn Syrup

8 fl oz (240 mL)

160 mg per 5 mL

Cherry

Flavor

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
  - muscular aches
  - backache
  - minor pain of arthritis
  - premenstrual and menstrual cramps

Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

dsdsds

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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 the user is taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if the user

■ has liver disease

■ is a child with pain of arthritis

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Directions

Weight (lb)	Age (years)	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.

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)

Overdose Warning (Overdose warning)

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

Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-177-08

Same as Children's TYLENOL ^®

with adult dosing

TYLENOL ^®

FOR CHILDREN

+ ADULTS FAMILY

Acetaminophen (160 mg per 5 mL)

Oral Suspension

Pain Reliever-Fever Reducer

DYE-FREE

Pain+Fever

Ages 2 Years – Adult

FREE OF:

Dyes

Alcohol

Ibuprofen

Aspirin

Parabens

High Fructose

Corn Syrup

8 fl oz (240 mL)

160 mg per 5 mL

Cherry

Flavor

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

Acetaminophen 160 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache muscular aches backache minor pain of arthritis premenstrual and menstrual cramps", "42229-5": "Drug Facts", "43683-2": "dsdsds", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if ■ pain gets worse or lasts more than 10 days in adults ■ pain gets worse or lasts more than 5 days in children under 12 years ■ 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 the user is taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if the user ■ has liver disease ■ is a child with pain of arthritis", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Pain reliever/fever reducer", "Directions": "■ do not give more than directed (see overdose warning) ■ shake well before using ■ mL = milliliter ■ Children 2 years to under 12 years: ■ find right dose on chart below. If possible, use weight to dose; otherwise, use age. ■ remove the child protective cap and squeeze the dose into the dosing cup ■ repeat dose every 4 hours while symptoms last ■ do not take more than 5 times in 24 hours unless directed by a doctor ■ do not take for more than 5 days unless directed by a doctor Weight (lb) Age (years) 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 ■ Adults and children 12 years and over: ■ take 20 mL (2 x 10 mL) every 4 hours while symptoms last. For adult dosing,the dosing cup needs to be filled to 10 mL line twice. ■ do not take more than 5 doses (100 mL) in 24 hours unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.", "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 ■ adult takes more than 4,000 mg of acetaminophen in 24 hours ■ child takes more than 5 doses in 24 hours, which is the maximum daily amount ■ taken with other drugs containing acetaminophen ■ adult has 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.", "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", "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.", "Inactive ingredients": "anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum", "Questions or comments?": "call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "NDC 50580-177-08 Same as Children's TYLENOL ® with adult dosing TYLENOL ® FOR CHILDREN + ADULTS FAMILY Acetaminophen (160 mg per 5 mL) Oral Suspension Pain Reliever-Fever Reducer DYE-FREE Pain+Fever Ages 2 Years – Adult FREE OF: Dyes Alcohol Ibuprofen Aspirin Parabens High Fructose Corn Syrup 8 fl oz (240 mL) 160 mg per 5 mL Cherry Flavor", "Active ingredient (in each 5 mL)": "Acetaminophen 160 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:09.481648 · Updated: 2026-03-14T23:08:47.595357