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Childrens ACCUDIAL Pain reliever/ Fever reducer

Medically reviewed on May 3, 2018

Dosage form: suspension
Ingredients: Acetaminophen 160mg in 5mL
Labeler: Accudial Pharmaceutical, Inc.
NDC Code: 45014-137

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 reliever/ Fever reducer

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

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.

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.

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.

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

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

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 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

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 red #40, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum



Palm Beach Gardens, FL 33408



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.



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

NDC 45014-137-04

acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-137
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Corn Syrup 
FD&C red no. 40 
D&C red no. 33 
Cellulose, Microcrystalline 
Carboxymethylcellulose Sodium 
Propylene Glycol 
Sodium benzoate 
Xanthan Gum 
Product Characteristics
FlavorBUBBLE GUMImprint Code
#Item CodePackage Description
1NDC:45014-137-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34304/25/2012
Labeler - Accudial Pharmaceutical, Inc. (831999201)

Accudial Pharmaceutical, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.