Childrens Pain And Fever Cherry Flavor Suspension
FDA Label NDC 0363-0322

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Childrens Pain And Fever Cherry Flavor (NDC 0363-0322). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Otc - Active Ingredient

Active ingredient
(in each 5 mL = 1 teaspoonful)
Acetaminophen 160 mg

Otc - Purpose

Purpose
Pain reliever/fever reducer

Indications & Usage

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

Warnings

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.

Otc - 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 other of
the inactive ingredients in this product.

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child

is taking the blood thinning drug warfarin.

Otc - When Using

When using this product do not exceed
recommended dose (see overdose warning)

Otc - Stop Use

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

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.

Dosage & 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.

Other Safety Information

Other information
■ each 5 mL (1 tsp) contains; sodium 3 mg
■ store between 20-25°C (68-77°F)
■ do not refrigerate
■ Keep carton for full directions for use.

Inactive Ingredient

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

Otc - Questions

Questions? Call weekdays from 9:30 AM to 4:30
PM EST at 1-877-798-5944

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

* Please review the disclaimer below.