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Childrens Pain and Fever

Dosage form
SUSPENSION
Labeler
AptaPharma Inc.
Label updated
2024-02-02
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN
View original label and images on DailyMed ↗
Label information

Drug Facts

유효 성분

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

성분·작용

Purpose
Pain reliever/fever reducer

효능·용도

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

주의사항

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.

Label information

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.

Label information

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

Label information

Ask a doctor or pharmacist before use if your child

is taking the blood thinning drug warfarin.

Label information

When using this product do not exceed

recommended dose (see overdose warning)

Label information

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.

Label information

Keep out of reach of children.

Label information

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.

복용법·사용법

Directions (Children's Pain & Fever)
■ 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.

Directions (Infants' Pain Relief)
■ 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)*
 Under 24  Under 2 years  Ask a doctor
 24-35  2-3 years  5 mL

*or as directed by a doctor

Attention: use only enclosed dosing syringe specifially
designed for use with this product. Do not use any
other dosing device.

Label information

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.

첨가제

Inactive ingredients anhydrous citric acid,
butylparaben. D&C Red #33. FD&C Blue #1. flavor,
glycerin, high fructose corn syrup, microcrystalline
cellulose and carboxymethylcellulose sodium.
propylene glycol, purified water, sodium benzoate,
sorbitol solution, sucralose, xanthan gum.

제조사 문의

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

PM EST at 1-877-798-5944

Product Label

AP SAFE ®​                     NDC 76821-526-24

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

Grape Flavor

DO NOT USE IF PRINTED NECK BAND IS
BROKEN OR MISSING

**This 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-06

Carton

[Image in the official label — see DailyMed source]

Bottle

[Image in the official label — see DailyMed source]

Carton

[Image in the official label — see DailyMed source]

Bottle

[Image in the official label — see DailyMed source]

res

DailyMed Set ID: 9064943f-836f-4853-b6f2-2c4879941eeb · Version 3
NDC: 76281-526