Your browser does not support JavaScript! before use docindia please enable Javascript on your browser

Children's ACCUDIAL® Pain reliever/ Fever reducer


SPL UNCLASSIFIED SECTION

Drug Facts


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:

Temporarily reduces fever

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

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.

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 SECTION

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 SECTION

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 SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.


OTC - WHEN USING SECTION

When using this product: Do not use more than directed.


OTC - STOP USE SECTION

Stop use and ask a doctor if:

These could be signs of a serious condition.

  • 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.

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.


Directions

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

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

under 6 mos.ask a doctor
6 mos. to under 22.5 mL or ½ tsp.
2 to under 45 mL or 1 tsp.
4 to under 67.5 mL or 1½ tsp.
6 to under 910 mL or 2 tsp.
9 to under 1112.5 mL or 2½ tsp.
11 to under 1215 mL or 3 tsp.
or as directed by a doctor
  • 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

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


SPL UNCLASSIFIED SECTION

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