Childrens Accudial
FDA Label NDC 45014-136

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Accudial Pharmaceutical, Inc. for the product Childrens Accudial (NDC 45014-136). 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, otc - 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

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - Ask Doctor/pharmacist

→ Otc - When Using

→ Otc - Stop Use

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 120 Ml Bottle Carton

Other

Drug Facts

DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC.
Palm Beach Gardens, FL 33408

Active Ingredient (In Each 5 Ml = 1 Teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains due to:

the common cold
flu
headache
sore throat
toothache

Temporarily reduces fever

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.

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 of the inactive ingredients in this product.

Otc - Ask Doctor

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

Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.

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 use more than directed.

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 occur.
Redness or swelling is present.

These could be signs of a serious condition.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Directions

This product does not contain directions or complete warnings for adult use.

shake well before using
if needed, repeat dose every 4 hours
do not use more than 5 times in 24 hours
when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose.
when weight is unknown: use the age chart on the rotating label.
use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device

Age (yr)	Dose (mL or tsp)
tsp. = teaspoon
mL = milliliter
under 6 mos.	ask a doctor
6 mos. to under 2	2.5 mL or ½ tsp.
2 to under 4	5 mL or 1 tsp.
4 to under 6	7.5 mL or 1½ tsp.
6 to under 9	10 mL or 2 tsp.
9 to under 11	12.5 mL or 2½ tsp.
11 to under 12	15 mL or 3 tsp.
or as directed by a doctor

Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.

Other Information

each teaspoon contains: sodium 2 mg
store between 20°-25°C (68°-77°F)
tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Inactive Ingredients

artificial flavor, citric acid anhydrous, corn syrup, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.