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Childrens Acetaminophen by R3 Pharmaceuticals, LLC

Medically reviewed on September 25, 2017

Dosage form: suspension
Ingredients: Acetaminophen 160mg in 5mL
Labeler: R3 Pharmaceuticals, LLC
NDC Code: 59999-001

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 Acetaminophen Oral Suspension

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • 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.

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
  • 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 or pharmacist before use if your child is taking the blood thinning drug warfarin.

When using this product do not exceed recommended dose (see overdose warning)

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 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
  • do not give more than directed (see Liver and overdose warning)
  • shake well before use
  • this product does not contain directions or complete warnings for adult use
  • use only with enclosed dosing cup
  • repeat dose every 4 hours if needed
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • find right dose on chart below. If possible, use weight to dose, otherwise; use age.
Weight (lb)Age (yr)Dose (tsp or mL)
under 24under 2 yearsask a doctor
24-352-3 years1 tsp or 5 mL
36-474-5 years1 1/2 tsp or 7.5 mL
48-596-8 years2 tsp or 10 mL
60-719-10 years2 1/2 tsp or 12.5 mL
72-9511 years3 tsp or 15 mL

Other information
  • each teaspoon contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Questions?

Call 601-859-0038

Distributed by: R3 Pharmaceuticals,LLC
Canton, MS 39046

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC 59999-001-04

SEE NEW WARNINGS INFORMATION

*Compare to the active ingredient in
Children's Tylenol® Oral Suspension*

Children's
Acetaminophen
oral suspension

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

fever reducer/
pain reliever

AGE
2-11
YEARS

Grape Flavor

R3 Pharmaceuticals

4 FL OZ (118 mL)

CHILDRENS ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59999-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
CARRAGEENAN 
D&C RED NO. 33 
FD&C BLUE NO. 1 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59999-001-041 BOTTLE, PLASTIC in 1 CARTON
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34309/23/2013
Labeler - R3 Pharmaceuticals, LLC (078888843)

 
R3 Pharmaceuticals, LLC

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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.

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