6509a545-0036-460a-8f0d-b31caae17855

Set ID
6509a545-0036-460a-8f0d-b31caae17855
Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2026-03-24
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:34

Key Label Information

Active Ingredients And Purpose

Drug Facts

Active ingredient (in each 5 mL) Acetaminophen, USP 160 mg

Purpose

Pain reliever/fever reducer

Uses

Uses

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

Warnings

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. 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

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

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

Directions And Dosage

Directions

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 Label Information

Other information

each 5 mL contains: sodium 6 mg store at 20° to 25°C (68° to 77°F) do not use if shrink sleeves is broken or missing

Inactive ingredients

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 2 FL OZ (60 mL) Container Label

AUROHEALTH NDC 58602-169-11 INFANTS’ PAIN & FEVER Suspension Liquid Acetaminophen Oral Suspension 160 mg per 5 mL Pain Reliever & Fever Reducer Alcohol, Aspirin, Ibuprofen & Gluten Free Dye-Free Grape Flavor Use ONLY enclosed syringe 2 FL OZ (60 mL)

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

NDC 58602-169-11 **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 Alcohol Free Aspirin Free Ibuprofen Free Gluten Free Dye-Free Grape Flavor Use ONLY enclosed syringe 2 FL OZ (60 mL)

Products

NDC Codes

Ingredients

NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
BUTYLPARABEN3QPI1U3FV8IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GRAPE6X543N684KIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
NONCRYSTALLIZING SORBITOL SOLUTION9E0S3UM200IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Complete SPL Sections

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 using 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

each 5 mL contains: sodium 6 mg 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

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 2 FL OZ (60 mL) Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH NDC 58602-169-11 INFANTS’ PAIN & FEVER Suspension Liquid Acetaminophen Oral Suspension 160 mg per 5 mL Pain Reliever & Fever Reducer Alcohol, Aspirin, Ibuprofen & Gluten Free Dye-Free Grape Flavor Use ONLY enclosed syringe 2 FL OZ (60 mL)

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-169-11 **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 Alcohol Free Aspirin Free Ibuprofen Free Gluten Free Dye-Free Grape Flavor Use ONLY enclosed syringe 2 FL OZ (60 mL)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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