Children's Tylenol

SPL v10

SPL

SPL Set ID 9782fe86-d72a-4231-b1ba-d3f3b4ee49e3

Route

ORAL

Published

Effective Date 2024-04-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Crospovidone Anhydrous Citric Acid Cellulose Acetate D&c Red No. 7 D&c Red No. 30 Aluminum Oxide Dextrose, Unspecified Form Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Povidone, Unspecified Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: TY;160;HALF;HALF Shape: round Color: purple Size: 16 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-02-27

Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

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

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)
chew or crush tablets completely before swallowing; do not swallow tablets whole
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (tablets) or as directed by a doctor
under 24	under 2 years	ask a doctor
24-35	2-3 years	1 tablet
36-47	4-5 years	1½ tablets
48-59	6-8 years	2 tablets
60-71	9-10 years	2½ tablets
72-95	11 years	3 tablets

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.

Other Information

store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
do not use if foil inner seal imprinted with "TYLENOL" is broken or missing

Inactive Ingredients

anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, D&C red no. 30 aluminum lake, dextrose, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, povidone, sucralose

Questions Or Comments?

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

Principal Display Panel

NDC 50580-522-24

Children's

TYLENOL ^®

Acetaminophen

Pain Reliever

Fever Reducer

Ibuprofen Free

Aspirin Free

Pain+Fever

Ages 2-11

Chewables

Chew or crush tablets completely

before swallowing

160 mg

Per Tablet

24 Chewable Tablets

160 mg each

Actual Size

Grape Flavor

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 Chewable Tablet)

Acetaminophen 160 mg

Structured Label Content

Uses

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

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)
chew or crush tablets completely before swallowing; do not swallow tablets whole
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (tablets) or as directed by a doctor
under 24	under 2 years	ask a doctor
24-35	2-3 years	1 tablet
36-47	4-5 years	1½ tablets
48-59	6-8 years	2 tablets
60-71	9-10 years	2½ tablets
72-95	11 years	3 tablets

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

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). Avoid high humidity. Protect from light.
do not use if foil inner seal imprinted with "TYLENOL" is broken or missing

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 50580-522-24

Children's

TYLENOL ^®

Acetaminophen

Pain Reliever

Fever Reducer

Ibuprofen Free

Aspirin Free

Pain+Fever

Ages 2-11

Chewables

Chew or crush tablets completely

before swallowing

160 mg

Per Tablet

24 Chewable Tablets

160 mg each

Actual Size

Grape Flavor

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 Chewable Tablet) (Active ingredient (in each chewable tablet))

Acetaminophen 160 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache temporarily reduces fever", "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 ) chew or crush tablets completely before swallowing; do not swallow tablets whole find right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 1 tablet 36-47 4-5 years 1½ tablets 48-59 6-8 years 2 tablets 60-71 9-10 years 2½ tablets 72-95 11 years 3 tablets", "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.", "Other information": "store between 20-25°C (68-77°F). Avoid high humidity. Protect from light. do not use if foil inner seal imprinted with "TYLENOL" is broken or missing", "Inactive ingredients": "anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, D&C red no. 30 aluminum lake, dextrose, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, povidone, sucralose", "Questions or comments?": "call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)", "PRINCIPAL DISPLAY PANEL": "NDC 50580-522-24 Children's TYLENOL ® Acetaminophen Pain Reliever Fever Reducer Ibuprofen Free Aspirin Free Pain+Fever Ages 2-11 Chewables Chew or crush tablets completely before swallowing 160 mg Per Tablet 24 Chewable Tablets 160 mg each Actual Size Grape Flavor", "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 chewable tablet)": "Acetaminophen 160 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:11.909706 · Updated: 2026-03-14T23:04:45.358873