Children's Pain & Fever

SPL v2

SPL

SPL Set ID 64c65244-f7a3-401b-b83a-bf66d45268e2

Route

ORAL

Published

Effective Date 2020-11-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Anhydrous Citric Acid Butylparaben Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Cellulose, Microcrystalline Carboxymethylcellulose Sodium Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-11-05

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Liver warning

This product contains acetaminophen. Severe liver

damage may occur nyour 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 ever, headache, rash.

nausea or vomiting, consult a doctor promptly.

Indications and Usage

Uses temporarily ■ reduces fever

■ relieves minor aches and pains due to:

■ the common cold ■ flu ■ headache ■ sore throat

■ toothache

Dosage and Administration

Directions

■ this product does not contain directions or

   complete warnings for adult use.

■ shake well before using

■ mL = milliliter; tsp = teaspoonful

■ find the right dose on the chart below. If possible, use

   weight to dose, otherwise, use age.

■ if needed, repeat dose every 4 hours while

   symptoms last

■ do not give more than 5 times in 24 hours

■ do not give for more than 5 days unless directed

by a doctor.

Weight (lb)	Age (yr)	Dose (mL or tsp)*
under 24	under 2 years	ask a doctor
24-35	2 - 3 years	5 mL (1 tsp)
36-47	4 - 5 years	7.5 mL (1 1/2 tsp)
48-59	6 - 8 years	10 mL (2 tsp)
60-71	9 - 10 years	12.5. mL (2 1/2 tsp)
72-95	11 years	15 mL (3 tsp)

*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.

Description

Drug Facts

Section 34088-5

Overdose warning

Taking more than the recommended dose (overdose)

may cause liver damage. 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 ■ 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 other of

the inactive ingredients in this product.

Section 51727-6

Inactive ingredients Anhydrous citric acid,

butylparaben, FD&C red #40 flavor, glycerin, high

fructose corn syrup, microcrystalline cellulose and

carboxymethylcellulose sodium, propylene glycol,

purified water. sodium benzoate, sorbitol solution,

sucralose, xanthan gum

Section 53413-1

Questions? Call weekdays from 9:30 AM to 4:30

PM EST at 1-877-798-5944

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Section 60561-8

Other information

■ each 5 mL (1 tsp) contains; sodium 3 mg

■ store between 20-25ºC (68-77ºF)

■ do not refrigerate

■ Keep carton for full directions for use.

Product Label

Walgreens

Compare to Children's Tylenol^®

Oral Suspension active ingredient ^††

NDC 0363-0322-24

children's

Pain & Fever

ACETAMINOPHEN

160 mg PER 5 mL

PAIN RELIEVER /

FEVER REDUCER

ORAL SUSPENSION

ALCOHOL FREE

ASPIRIN FREE

IBUPROFEN FREE

AGES

2-11

YEARS

CHERRY FLAVOR

4 FL OZ (118 mL)

This product is bot manufactured or distributed by Johnson

& Johnson Consumer Inc., |McNeil Consumer Healthcare,

distributor of Children's Tylenol^® Oral Suspension.

ITEM 268958 W00000-0000-0

REV-1020

DO NOT USE IF PRINTED NECKBAND IS

BROKEN OR MISSING

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

DISTRIBUTED BY WALGREEN CO.

200 WILMONT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2020 Walgreen Co.

DOSAGE

CUP PROVIDED

BX-113

ORG1020-F

Carton

Bottle

res

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily ■ reduces fever

■ relieves minor aches and pains due to:

■ the common cold ■ flu ■ headache ■ sore throat

■ toothache

Dosage and Administration (34068-7)

Weight (lb)	Age (yr)	Dose (mL or tsp)*
under 24	under 2 years	ask a doctor
24-35	2 - 3 years	5 mL (1 tsp)
36-47	4 - 5 years	7.5 mL (1 1/2 tsp)
48-59	6 - 8 years	10 mL (2 tsp)
60-71	9 - 10 years	12.5. mL (2 1/2 tsp)
72-95	11 years	15 mL (3 tsp)

*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.

Warnings and Precautions (34071-1)

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 ever, headache, rash.

nausea or vomiting, consult a doctor promptly.

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)

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 51727-6 (51727-6)

Section 53413-1 (53413-1)

Questions? Call weekdays from 9:30 AM to 4:30

PM EST at 1-877-798-5944

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Section 60561-8 (60561-8)

Other information

■ each 5 mL (1 tsp) contains; sodium 3 mg

■ store between 20-25ºC (68-77ºF)

■ do not refrigerate

■ Keep carton for full directions for use.

Product Label

Walgreens

Compare to Children's Tylenol^®

Oral Suspension active ingredient ^††

NDC 0363-0322-24

children's

Pain & Fever

ACETAMINOPHEN

160 mg PER 5 mL

PAIN RELIEVER /

FEVER REDUCER

ORAL SUSPENSION

ALCOHOL FREE

ASPIRIN FREE

IBUPROFEN FREE

AGES

2-11

YEARS

CHERRY FLAVOR

4 FL OZ (118 mL)

This product is bot manufactured or distributed by Johnson

& Johnson Consumer Inc., |McNeil Consumer Healthcare,

distributor of Children's Tylenol^® Oral Suspension.

ITEM 268958 W00000-0000-0

REV-1020

DO NOT USE IF PRINTED NECKBAND IS

BROKEN OR MISSING

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

DISTRIBUTED BY WALGREEN CO.

200 WILMONT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2020 Walgreen Co.

DOSAGE

CUP PROVIDED

BX-113

ORG1020-F

Carton

Bottle

res

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache", "34068-7": "Directions ■ this product does not contain directions or complete warnings for adult use. ■ shake well before using ■ mL = milliliter; tsp = teaspoonful ■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age. ■ if needed, repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours ■ do not give for more than 5 days unless directed by a doctor. Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 years ask a doctor 24-35 2 - 3 years 5 mL (1 tsp) 36-47 4 - 5 years 7.5 mL (1 1/2 tsp) 48-59 6 - 8 years 10 mL (2 tsp) 60-71 9 - 10 years 12.5. mL (2 1/2 tsp) 72-95 11 years 15 mL (3 tsp) * 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.", "34071-1": "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur nyour 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 ever, headache, rash. nausea or vomiting, consult a doctor promptly.", "34088-5": "Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. 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 ■ 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 other of the inactive ingredients in this product.", "51727-6": "Inactive ingredients Anhydrous citric acid, butylparaben, FD&C red #40 flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water. sodium benzoate, sorbitol solution, sucralose, xanthan gum", "53413-1": "Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944", "55105-1": "Purpose Pain reliever/fever reducer", "55106-9": "Active ingredient (in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg", "60561-8": "Other information ■ each 5 mL (1 tsp) contains; sodium 3 mg ■ store between 20-25ºC (68-77ºF) ■ do not refrigerate ■ Keep carton for full directions for use.", "Product Label": "Walgreens Compare to Children's Tylenol ® Oral Suspension active ingredient †† NDC 0363-0322-24 children's Pain & Fever ACETAMINOPHEN 160 mg PER 5 mL PAIN RELIEVER / FEVER REDUCER ORAL SUSPENSION ALCOHOL FREE ASPIRIN FREE IBUPROFEN FREE AGES 2-11 YEARS CHERRY FLAVOR 4 FL OZ (118 mL) This product is bot manufactured or distributed by Johnson & Johnson Consumer Inc., |McNeil Consumer Healthcare, distributor of Children's Tylenol ® Oral Suspension. ITEM 268958 W00000-0000-0 REV-1020 DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING Walgreens Pharmacist Recommended Walgreens Pharmacist Survey DISTRIBUTED BY WALGREEN CO. 200 WILMONT RD., DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2020 Walgreen Co. DOSAGE CUP PROVIDED BX-113 ORG1020-F Carton Bottle res"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:36.551754 · Updated: 2026-03-14T23:02:16.200124