Childrens ACCUDIAL Pain reliever/ Fever reducer

Drug Facts

Acetaminophen 160 mg

Pain reliever/fever reducer

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.

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 of the inactive ingredients in this product.

Label information

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.

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 use more than directed.

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 occur.
• Redness or swelling is present.

These could be signs of a serious condition.

Keep out of reach of children.

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.

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.

• 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.

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

877-434-2036

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

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

Bubblegum
Flavor

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

NDC 45014-137-04

[Image in the official label — see DailyMed source]