FDA Label for Childrens Accudial Pain Reliever/ Fever Reducer

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.

Questions?

877-434-2036

Principal Display Panel - 120 Ml Bottle Carton

Children's
ACCUDIAL_®

Acetaminophen
Oral Suspension

Pain Reliever / Fever Reducer

For ages 6 mos. to
under 12 yrs. or 12-95 lbs.

Alcohol Free • Aspirin Free • Ibuprofen Free

Compares to the active
ingredient in Children's
Tylenol^® Oral Suspension.

ROTATING
LABEL FOR
WEIGHT-BASED
DOSING

Grape
Flavor

4 FL.OZ. (120 mL)
80 mg per 1/2 teaspoon
(160 mg per 5 mL)

NDC 45014-136-04

Principal Display Panel - pain reliever 01