FDA Label for Pain And Fever

View Indications, Usage & Precautions

Pain And Fever Product Label

The following document was submitted to the FDA by the labeler of this product Accudial Pharmaceutical, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


When Using This Product



Do not exceed recommended dose.


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). Quick medical attention is critical, even if you do not notice any signs or symptoms.


Directions



  • shake well before using
  • if needed, repeat dose every 4 hours
  • do not use more than 5 times in 24 hours
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
  • Age (yr)Dose (mL or tsp)
    under 2 yearsask a doctor
    2-3 years5 mL or 1 tsp.
    4-5 years7.5 mL or 1½ tsp.
    6-8 years10 mL or 2 tsp.
    9-10 years12.5 mL or 2½ tsp.
    11 years15 mL or 3 tsp.

Other Information



  • each teaspoon contains: sodium 2 mg

Storage & Package Safety



  • do not use if inner foil seal is broken or missing
  • store between 20°-25°C (68°-77°F)
  • see bottom panel for lot number and expiration date

Inactive Ingredients



artificial flavor, citric acid, corn syrup, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethyl cellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.


Questions?



877-434-2036


Principal Display Panel - 120 Ml Carton



CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

ACCURATE DOSING BY WEIGHT

CONTAINS
Acetaminophen
Oral Suspension

Pain Reliever,
Fever Reducer
For Ages 2 to under 12

Alcohol Free • Aspirin Free • Ibuprofen Free

80 mg per 1/2 teaspoon
(160 mg per 5 mL)

CHERRY
FLAVOR

Compares to
Children's
Tylenol ®.

4 FL.OZ.
(120 mL)
NDC 45014-131-04


* Please review the disclaimer below.