DrugCite

ACETAMINOPHEN - acetaminophen liquid 
Accudial Pharmaceutical, Inc.

Children's
ACCUDIAL®
Acetaminophen
Oral Solution

Drug Facts

Active ingredient Purpose (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

  • 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.

Directions

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)
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
tsp. = teaspoon mL = milliliter

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 USP, D&C Red #33, FD&C Red #40, glycerin USP, non-crystalline sorbitol 70% USP, polyethylene glycol NF, propylene glycol, purified water, sodium benzoate, sodium saccharin.

Questions?

877-434-2036

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

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

Children's
ACCUDIAL®

Acetaminophen
Oral Solution

Pain Reliever / Fever Reducer

For ages 6 mos. to
under 12 or 12-95 lbs.

Alcohol Free • Aspirin Free • Ibuprofen Free

Compares to the active
ingredient in Children's
Tylenol® Oral Solution.

ROTATING
LABEL FOR
WEIGHT-BASED
DOSING

Cherry Flavor

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

NDC 45014-130-04

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

ACETAMINOPHEN 
acetaminophen  liquid
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 45014-130
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (acetaminophen) Acetaminophen 160 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin  
Sorbitol  
Sodium Benzoate  
Anhydrous citric acid  
FD&C Red no. 40  
Water  
saccharin sodium  
Propylene glycol  
Prunus Serotina Bark  
POLYETHYLENE GLYCOL 1450  
D&C RED NO. 33  
Product Characteristics
Color RED Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 45014-130-04 120 mL In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 10/01/2023

Labeler - Accudial Pharmaceutical, Inc. (831999201)
Revised: 10/2011Accudial Pharmaceutical, Inc.