Childrens Acetaminophen
FDA Label NDC 59999-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by R3 Pharmaceuticals, Llc for the product Childrens Acetaminophen (NDC 59999-001). 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, active ingredient (in each 5 ml = 1 teaspoon), purpose, uses, liver warning, sore throat warning, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient (in Each 5 Ml = 1 Teaspoon)

→ Purpose

→ Uses

→ Liver Warning

→ Sore Throat Warning

→ Do Not Use

→ Otc - Ask Doctor

→ Otc - Ask Doctor/pharmacist

→ Otc - When Using

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 118 Ml Bottle Carton

Other

Drug Facts

Distributed by: R3 Pharmaceuticals,LLC
Canton, MS 39046

Active Ingredient (In Each 5 Ml = 1 Teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

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

Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash nausea, or vomiting consult a doctor promptly.

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
if your child is allergic to acetaminophen or any 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)

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 occur
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.

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 even if you do not notice any signs or symptoms.

Directions

do not give more than directed (see Liver and overdose warning)
shake well before use
this product does not contain directions or complete warnings for adult use
use only with enclosed dosing cup
repeat dose every 4 hours if needed
do not give more than 5 times in 24 hours
do not give for more than 5 days unless directed by a doctor
find right dose on chart below. If possible, use weight to dose, otherwise; use age.

Weight (lb)	Age (yr)	Dose (tsp or mL)
under 24	under 2 years	ask a doctor
24-35	2-3 years	1 tsp or 5 mL
36-47	4-5 years	1 1/2 tsp or 7.5 mL
48-59	6-8 years	2 tsp or 10 mL
60-71	9-10 years	2 1/2 tsp or 12.5 mL
72-95	11 years	3 tsp or 15 mL

Other Information

each teaspoon contains: sodium 3 mg
store at 20°-25°C (68°-77°F)

Inactive Ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution