INFANTS Pain and Fever - Aurohealth LLC | APL HEALTHCARE LIMITED

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2026-05-20
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:21

Label at a glance#

ProductINFANTS 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. If possible, use weight to dose; otherwise, use age. use only enclosed syringe designed for use with this product. Do not use any other dosing device. remove bottle cap and insert syringe tip through opening at top of th...

Storage and handling

store at 20° to 25°C (68° to 77°F) do not use if shrink sleeves is broken or missing

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. If possible, use weight to dose; otherwise, use age.
  • use only enclosed syringe designed for use with this product. Do not use any other dosing device.
  • remove bottle cap and insert syringe tip through opening at top of the bottle
  • tip bottle upside down and draw medicine into the syringe
  • fill to dose level
  • dispense liquid slowly into child’s mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child resistance
Dosing Chart
Weight (lb)
Age (yr)
Dose (mL)*
* or as directed by a doctor
under 24
under 2 years
ask a doctor
24-35 lbs
2-3 years
5 mL

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

Other information

STORAGE AND HANDLING SECTION

  • store at 20° to 25°C (68° to 77°F)
  • do not use if shrink sleeves is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid anhydrous, flavor, glycerin, 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 2 FL OZ (60 mL) Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH                              NDC 58602-172-11

INFANTS' PAIN & FEVER
Suspension Liquid

Acetaminophen Oral Suspension
160 mg per 5 mL

Pain Reliever & Fever Reducer
Dye, Parabens, High Fructose Corn
Syrup, Sugar, Alcohol, Aspirin, Ibuprofen,
Gluten, GMO Free & No Artificial Flavor

Natural Cherry Flavor
Use ONLY enclosed syringe

 2 FL OZ (60 mL)

  PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 2 FL OZ (60 mL) Container LabelPACKAGE LABEL-PRINCIPAL DISPLAY PANEL 2 FL OZ (60 mL) Container Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 2 FL OZ (60 mL) Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-172-11
**Compare to Infants'
TYLENOL® Oral Suspension
active ingredient
 

AUROHEALTH                              

INFANTS'
PAIN & FEVER
Suspension Liquid

Acetaminophen Oral Suspension
160 mg per 5 mL

Pain Reliever & Fever Reducer
 

• Dye Free                    • Sugar Free 

• Alcohol Free              • Aspirin Free 

• Parabens Free            • Ibuprofen Free 

• High Fructose            • Gluten Free 

  Corn Syrup Free        • GMO Free 

• No Artificial Flavor

Natural Cherry Flavor
Use ONLY enclosed syringe

2 FL OZ (60 mL)

 

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 2 FL OZ (60 mL) Carton LabelPACKAGE LABEL-PRINCIPAL DISPLAY PANEL 2 FL OZ (60 mL) Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN1
307668acetaminophen 32 MG/ML Oral SuspensionSCD1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY1
307668APAP 32 MG/ML Oral SuspensionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-172-11INFANTS Pain and Fever1 in 1 CARTONSUSPENSION11
58602-172-11INFANTS Pain and Fever60 mL in 1 BOTTLESUSPENSION601

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-17258602-172-11

Ingredients#

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

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

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
INFANTS Pain and FeverACETAMINOPHENAurohealth LLCb3f57af5-661f-4534-9eed-76e431f338db2026-05-20WarningsExact identifier
ndc (package): 58602-172-11
ndc (product): 58602-172
ndc11 (package): 58602017211
spl id: b3f57af5-661f-4534-9eed-76e431f338db
spl set id: b3f57af5-661f-4534-9eed-76e431f338db

Reported adverse events (FAERS/openFDA)#

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