Childrens Acetaminophen Suspension
FDA Label NDC 81033-026

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kesin Pharma Corporation for the product Childrens Acetaminophen (NDC 81033-026). 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 active ingredient (in each 5 ml), purpose, uses, warnings, do not use, stop use and ask a doctor if, otc - keep out of reach of children, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each 5 Ml)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Overdosage

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Other

→ Package Label.principal Display Panel

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Temporarily reduces fever
Temporarily relieves minor aches and pains due to:

the common cold
flu
headaches
sore throat
toothaches

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your 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, persistent for more than 2 days, is accompanied
or followed by fever, headache, nausea, rash, or vomiting, consult a doctor promptly.

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 of the inactive ingredients in this product

Ask a doctor before use if the your child has liver disease
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
When using this product, do not exceed the recommended dose (see overdose warning)

Stop Use And Ask A Doctor If

symptoms do not improve
new symptoms occur
pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
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: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

this product does not contain directions or complete warnings for adult use
do not take more than directed (see overdose warning)
shake well before using
mL = milliliter
find the right dose on chart below. If possible, use weight to dose; otherwise, use age
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL)
Under 24	Under 2 years	Ask a doctor
24 to 35	2 to 3 years	5 mL
36 to 47	4 to 5 years	7.5 mL
48 to 59	6 to 8 years	10 mL
60 to 71	9 to 10 years	12.5 mL
72 to 95	11 years	15 mL

* or as directed by a doctor

Other Information

each 5 mL contains: sodium: < 5 mg
store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]
protect from freezing
a white to off-white, cherry flavored suspension supplied in the following oral dosage forms

NDC 81033-026-05: 5 mL unit-dose cup
NDC 81033-026-38: Carton containing 30 unit-dose cups of 5 mL each.
NDC 81033-026-01: Case containing 100 unit-dose cups of 5 mL each.
NDC 81033-026-10: 10.15 mL unit-dose cup
NDC 81033-026-39: Carton containing 30 unit-dose cups of 10.15 mL each.
NDC 81033-026-02: Case containing 100 unit-dose cups of 10.15 mL each.
NDC 81033-026-20: 20.13 mL unit-dose cup
NDC 81033-026-40: Carton containing 30 unit-dose cups of 20.13 mL each.

Inactive Ingredients

carboxymethylcellulose sodium, cherry flavor, citric acid, glycerin, microcrystalline cellulose, potassium sorbate, purified water, sorbitol, sucralose, sucrose, and xanthan gum.