Children’s Tylenol

SPL v6

SPL

SPL Set ID 8b516736-86ac-47cb-a0ec-038d4c3a0020

Route

ORAL

Published

Effective Date 2017-10-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg) Chlorpheniramine (1 mg) Dextromethorphan (5 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Anhydrous Citric Acid D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Form Water Sodium Benzoate Sorbitol Solution Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-06-26

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- cough
- stuffy nose
- sneezing and runny nose
temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 55105-1

Active ingredients (in each 5 mL)	Purpose
Acetaminophen 160 mg	Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg	Antihistamine
Dextromethorphan HBr 5 mg	Cough suppressant
Phenylephrine HCl 2.5 mg	Nasal decongestant

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) or as directed by a doctor
under 36	under 4 years	do not use
36-47	4 to 5 years	do not use unless directed by a doctor
48-95	6 to 11 years	10 mL

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.
to make a child sleepy
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
if your child is allergic to any of the 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.

Other Information

store between 20-25°C (68-77°F)
do not use if carton is opened or if carton tape or bottle wrap imprinted "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, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions Or Comments?

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

Principal Display Panel

NDC 50580-299-01

Children's

TYLENOL ^®

COLD +

FLU

Acetaminophen, Pain Reliever-Fever Reducer

Chlorpheniramine Maleate, Antihistamine

Dextromethorphan HBr, Cough Suppressant

Phenylephrine HCl, Nasal Decongestant

Oral Suspension

Ages 6-11 Years

FEVER
SORE THROAT
SNEEZING
RUNNY NOSE
COUGH
STUFFY NOSE

Grape

Flavor

4 fl oz (120 mL)

When Using This Product

do not exceed recommended dose (see overdose warning)
excitability may occur, especially in children
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If

nervousness, dizziness or sleeplessness occur
pain, nasal congestion or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Ask A Doctor Before Use If Your Child Has

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)
a breathing problem such as chronic bronchitis
glaucoma

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- cough
- stuffy nose
- sneezing and runny nose
temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 55105-1 (55105-1)

Active ingredients (in each 5 mL)	Purpose
Acetaminophen 160 mg	Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg	Antihistamine
Dextromethorphan HBr 5 mg	Cough suppressant
Phenylephrine HCl 2.5 mg	Nasal decongestant

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) or as directed by a doctor
under 36	under 4 years	do not use
36-47	4 to 5 years	do not use unless directed by a doctor
48-95	6 to 11 years	10 mL

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.
to make a child sleepy
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
if your child is allergic to any of the 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)

Other Information (Other information)

store between 20-25°C (68-77°F)
do not use if carton is opened or if carton tape or bottle wrap imprinted "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)

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-299-01

Children's

TYLENOL ^®

COLD +

FLU

Acetaminophen, Pain Reliever-Fever Reducer

Chlorpheniramine Maleate, Antihistamine

Dextromethorphan HBr, Cough Suppressant

Phenylephrine HCl, Nasal Decongestant

Oral Suspension

Ages 6-11 Years

FEVER
SORE THROAT
SNEEZING
RUNNY NOSE
COUGH
STUFFY NOSE

Grape

Flavor

4 fl oz (120 mL)

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)
excitability may occur, especially in children
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness or sleeplessness occur
pain, nasal congestion or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)
a breathing problem such as chronic bronchitis
glaucoma

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves the following cold/flu symptoms: minor aches and pains headache sore throat cough stuffy nose sneezing and runny nose temporarily reduces fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "55105-1": "Active ingredients (in each 5 mL) Purpose Acetaminophen 160 mg Pain reliever/fever reducer Chlorpheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough suppressant Phenylephrine HCl 2.5 mg Nasal decongestant", "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) or as directed by a doctor under 36 under 4 years do not use 36-47 4 to 5 years do not use unless directed by a doctor 48-95 6 to 11 years 10 mL 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. to make a child sleepy in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. if your child is allergic to any of the 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.", "Other information": "store between 20-25°C (68-77°F) do not use if carton is opened or if carton tape or bottle wrap imprinted "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, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum", "Questions or comments?": "call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "NDC 50580-299-01 Children's TYLENOL ® COLD + FLU Acetaminophen, Pain Reliever-Fever Reducer Chlorpheniramine Maleate, Antihistamine Dextromethorphan HBr, Cough Suppressant Phenylephrine HCl, Nasal Decongestant Oral Suspension Ages 6-11 Years FEVER SORE THROAT SNEEZING RUNNY NOSE COUGH STUFFY NOSE Grape Flavor 4 fl oz (120 mL)", "When using this product": "do not exceed recommended dose (see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness", "Stop use and ask a doctor if": "nervousness, dizziness or sleeplessness occur pain, nasal congestion or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.", "Ask a doctor before use if your child has": "liver disease heart disease high blood pressure thyroid disease diabetes persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) a breathing problem such as chronic bronchitis glaucoma", "Ask a doctor or pharmacist before use if your child is": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:19.804957 · Updated: 2026-03-14T23:04:57.817577