Childrens Pain And Fever Suspension
FDA Label NDC 76281-525

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Childrens Pain And Fever (NDC 76281-525). 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 tsp0
 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 ingredientsanhydrous 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

AP SAFE®​                     NDC 76821-525-24

COMPARE TO THE

ACTIVE INGREDIENT IN

CHILDREN'S TYLENOL

ORAL SUSPENSION*

Children's

Pain

& Fever

Acetaminophen

Oral Suspension

Pain reliever/Fever Reducer

• Alcohol-Free
• Ibuprofen Free
• Aspirin Free
• For Ages 2 to 11

4 FL OZ (118 mL)

160 mg per 5 mL

Cherry Flavor

DO NOT USE IF PRINTED NECK BAND IS
BROKEN OR MISSINGThis

Product is not manufactured or distributed
by McNeil Consumer Healthcare, distributor of
Children's Tylenol®Oral Suspension.

Manufactured by:
AptaPharma Inc.
1533 Union Ave.
Pennsauken. NJ 08110

AP-BX-01 Rev. 01

Carton

Bottle

res

* Please review the disclaimer below.