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Acetaminophen by Healthlife of USA

Medically reviewed on January 9, 2018

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 100mL
Labeler: Healthlife of USA
NDC Code: 69517-623

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 Acetaminphen Oral Suspension 

Pain Reliever/ Fever Reducer 

Drug Facts

Active ingredient (in each 5mL)

Acetaminophen 160mg

Purpose

Fever reducer/ pain reliever

Uses

Temporarily:

  1. reduces fever
  2. 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.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whetgher 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 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
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition

Keep out of reach of children.

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • this product does not contain directions or complete warnings for adult use
  • mL=mililiter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • fill to dose level. Do not use any other dosing device
  • dispense liquid slowly into child's mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • rinse the dosing device after each use
  • do not give more than 5 times in 24 hours
  • shake well before use
  • do not give moer than directed.
 Weight (lb)Age (Year) DOse (mL)* 
 Under 24 Under 2 yearsAsk a doctor
24-35 2-3 years 5mL
36-47 4-5 years 7.5mL
48-59 6-8 years10mL
60-71 9-10 years12.5mL
72-95 11 years15mL

* or as directed by a doctor

Attention: Use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Other information
  • Store between 15°-30°C (59°-86°F)
  • Protect from freezing
  • Protect from light

Inactive ingredients

Acesulfame Potassium, Avicel, Butyl paraben, citric acid, FD&C Red #40, Glycerin, High fructose corn syrup, Nat cherry flavor, polysorbate 80, propylene glycol, sodium benzoate, sorbitol, sucralose, Prosweet N and A, Purified water, xanthan gum

Questions or comments?

Call 1-844-832-1138

Children's Acetaminophen Oral Suspension
Pain Reliever/ Fever Reducer

Distributed by:

Healthlife of USA

1600 Hart Street,

Rahway, NJ 07065

www.healthlifeofusa.com

ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-623
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
POLYSORBATE 80 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
WATER 
XANTHAN GUM 
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69517-623-171 BOTTLE in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/09/2018
Labeler - Healthlife of USA (079656178)
Establishment
NameAddressID/FEIOperations
Kingston Pharma LLC080386521manufacture(69517-623)

 
Healthlife of USA

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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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