FDA Label for Childrens Pain And Fever

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.

*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