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Pain and Fever by Accudial Pharmaceutical, Inc.

Medically reviewed on January 19, 2018

Dosage form: suspension
Ingredients: Acetaminophen 160mg in 5mL
Labeler: Accudial Pharmaceutical, Inc.
NDC Code: 45014-131

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

CHILDREN'S
ACCUDIAL
Pain & Fever

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:

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

temporarily reduces fever

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.

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.

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

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

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.

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). 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

PAIN AND FEVER 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-131
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Cherry 
Citric Acid Monohydrate 
Corn Syrup 
FD&C RED NO. 40 
Glycerin 
Cellulose, Microcrystalline 
CarboxymethylCellulose Sodium 
Propylene Glycol 
Water 
Sodium benzoate 
Sucralose 
Sorbitol 
Xanthan Gum 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45014-131-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34301/04/2010
Labeler - Accudial Pharmaceutical, Inc. (831999201)

 
Accudial Pharmaceutical, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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