FDA.reportPublic FDA data

Childrens Pain and Fever - Aurohealth LLC | APL HEALTHCARE LIMITED

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2026-07-24
Label type
Human OTC Drug Label
Version
1
Source
daily-update
Hydrated at
2026-07-28 05:10:12

Label at a glance#

ProductChildrens Pain and Fever
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 do not give more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child’s dose into the dosing cup repeat dose every 4 hours while symptoms last do not give more than 5 times in 2...

Storage and handling

each 5 mL contains: sodium 6 mg store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)

Acetaminophen, USP 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:


  • reduces fever
  • 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.

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.

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

OTC - DO NOT USE SECTION

  • 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

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.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose (see overdose warning).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and squeeze your child’s dose into the dosing cup
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
 
* or as directed by a doctor
Weight (lb)
Age (yr)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL
36-47
4-5 years
7.5 mL
48-59
6-8 years
10 mL
60-71
9-10 years
12.5 mL
72-95
11 years
15 mL

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

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 6 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylparaben, carboxymethylcellulose sodium, citric acid anhydrous, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, noncrystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum.


Questions or comments? 1-855-274-4122

Distributed by: AUROHEALTH LLC
279 Princeton-Hightstown Road,
East Windsor, NJ 08520

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL) Container Label

SPL UNCLASSIFIED SECTION

AUROHEALTH

NDC 58602-166-24

AGES 2-11 YEARS
Children's
PAIN & FEVER

Suspension Liquid

Acetaminophen Oral Suspension
160 mg per 5 mL

Pain Reliever & Fever Reducer

Alcohol, Aspirin, Ibuprofen
& Gluten Free


Dye-Free Cherry Flavor

Use ONLY enclosed
dosage cup

4 FL OZ (118 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL) Container LabelPACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL) Container Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL) Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-166-24

**Compare to Children's
TYLENOL® Oral Suspension
active ingredient

AUROHEALTH
AGES 2-11 YEARS
Children's
PAIN & FEVER

Suspension Liquid

Acetaminophen Oral Suspension
160 mg per 5 mL

Pain Reliever & Fever Reducer

Alcohol Free
Aspirin Free
Ibuprofen Free
Gluten Free

Dye-Free Cherry Flavor

Use ONLY enclosed
dosage cup

4 FL OZ (118 mL)

 

   PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL) Carton LabelPACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL) Carton Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-16658602-166-24, 58602-166-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BUTYLPARABEN3QPI1U3FV8IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CHERRYBUC5I9595WIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
NONCRYSTALLIZING SORBITOL SOLUTION9E0S3UM200IACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Pain and FeverACETAMINOPHENAurohealth LLC5ada044e-50e8-4874-ac04-df5f1f9e735d2026-07-24WarningsExact identifier
ndc (package): 58602-166-24
ndc (package): 58602-166-20
ndc (product): 58602-166
ndc11 (package): 58602016620
ndc11 (package): 58602016624
spl id: 5ada044e-50e8-4874-ac04-df5f1f9e735d
spl set id: 5ada044e-50e8-4874-ac04-df5f1f9e735d

Reported adverse events (FAERS/openFDA)#

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