Children's Acetaminphen Oral Suspension Pain Reliever/ Fever Reducer

Manufacturer
Healthlife of USA | Kingston Pharma LLC
Effective date
2018-04-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:59:29

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure15 sections

Indications and uses

Temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient (in each 5mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160mg

Purpose

OTC - PURPOSE SECTION

Fever reducer/ pain reliever

Uses

INDICATIONS & USAGE SECTION

Temporarily:

  1. reduces fever
  2. relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

Overdose warning:

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-844-832-1138

Children's Acetaminophen Oral Suspension Pain Reliever/ Fever Reducer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by:

Healthlife of USA

1600 Hart Street,

Rahway, NJ 07065

www.healthlifeofusa.com

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FDA-Initiated Inactive NDC Indexing#

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-62369517-623-17

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0846de12-2d2a-1082-e063-6394a90a829ad2dfd669-701c-403c-ad07-67e9d712d5de2023-10-21WarningsExact identifier
spl set id: d2dfd669-701c-403c-ad07-67e9d712d5de

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.