Infants' Tylenol

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

D&c Red No. 33 Fd&c Blue No. 1 Glycerin High Fructose Corn Syrup Microcrystalline Cellulose Anhydrous Citric Acid 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 2017-08-07

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

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. If possible, use weight to dose; otherwise, use age.
push air out of syringe. Insert syringe tip into bottle opening
flip bottle upside down. Pull yellow part of syringe to correct dose
dispense liquid slowly into child's mouth, toward inner cheek
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
replace cap tightly to maintain child resistance

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL) or as directed by a doctor
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL

Attention: use only enclosed syringe 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Other Information

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

Questions Or Comments?

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

Principal Display Panel

NDC 50580-433-01

Infants'

TYLENOL ^®

For Children

Acetaminophen 160 mg per 5 mL Oral Suspension

Pain Reliever-Fever Reducer

Pain + Fever

Infants

Alcohol Free

Ibuprofen Free

Aspirin Free

No Parabens

SimpleMeasure ^®

Specially designed for younger children

Use Only Enclosed Syringe

1 fl oz (30 mL)

160 mg per 5 mL*

Grape Flavor

*Same as Children's TYLENOL

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.

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

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. If possible, use weight to dose; otherwise, use age.
push air out of syringe. Insert syringe tip into bottle opening
flip bottle upside down. Pull yellow part of syringe to correct dose
dispense liquid slowly into child's mouth, toward inner cheek
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
replace cap tightly to maintain child resistance

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL) or as directed by a doctor
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL

Attention: use only enclosed syringe 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Other Information (Other information)

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

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 50580-433-01

Infants'

TYLENOL ^®

For Children

Acetaminophen 160 mg per 5 mL Oral Suspension

Pain Reliever-Fever Reducer

Pain + Fever

Infants

Alcohol Free

Ibuprofen Free

Aspirin Free

No Parabens

SimpleMeasure ^®

Specially designed for younger children

Use Only Enclosed Syringe

1 fl oz (30 mL)

160 mg per 5 mL*

Grape Flavor

*Same as Children's TYLENOL

Stop Use and Ask A Doctor If (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.

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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "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", "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. If possible, use weight to dose; otherwise, use age. push air out of syringe. Insert syringe tip into bottle opening flip bottle upside down. Pull yellow part of syringe to correct dose dispense liquid slowly into child's mouth, toward inner cheek repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours replace cap tightly to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL Attention: use only enclosed syringe 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product", "Other information": "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", "Questions or comments?": "call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "NDC 50580-433-01 Infants' TYLENOL ® For Children Acetaminophen 160 mg per 5 mL Oral Suspension Pain Reliever-Fever Reducer Pain + Fever Infants Alcohol Free Ibuprofen Free Aspirin Free No Parabens SimpleMeasure ® Specially designed for younger children Use Only Enclosed Syringe 1 fl oz (30 mL) 160 mg per 5 mL* Grape Flavor *Same as Children's TYLENOL", "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.", "Active ingredient (in each 5 mL)": "Acetaminophen 160 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information