Childrens Pain and Fever

Manufacturer
Aurohealth LLC
Effective date
2020-11-19
Label type
Human OTC Drug Label
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:05:14

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) do not use if printed seal over cap is torn or missing see bottom panel for lot number and expiration date

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.
  • for more than 10 days for pain unless directed by a doctor.
  • for more than 3 days for fever unless directed by a doctor.
  • 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

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt 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)
  • do not use if printed seal over cap is torn or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

1-855-274-4122


Distributed by: Aurohealth LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648

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

SPL UNCLASSIFIED SECTION

NDC 58602-503-24
PrimaryHealth
Ages 2-11 years
Children's

Pain &
Fever

SUSPENSION LIQUID
Pain Reliever & Fever Reducer
ACETAMINOPHEN
ORAL SUSPENSION
160 mg per 5 mL
• Alcohol Free
• Aspirin Free 
• Ibuprofen Free
• Gluten Free
Dye-Free
Cherry Flavor
Use ONLY enclosed dosage cup
DO NOT USE IF PRINTED SEAL OVER
CAP IS TORN OR MISSING

4 FL OZ (118 mL)


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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-503-24
PrimaryHealth
Compare To Children's
TYLENOL® Oral Suspension
active ingredient**
Ages 2-11 years
Children's

Pain &
Fever
SUSPENSION LIQUID
Pain Reliever & Fever Reducer
ACETAMINOPHEN
ORAL SUSPENSION
160 mg per 5 mL
• 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 Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-50358602-503-24

Ingredients#

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

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

Source Document#

Source XML · Source PDF

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
9a42f787-2d06-4cba-b74c-8bc89aabda28ca302b01-0a5e-4ccb-96ba-86a7a774199b2020-11-19WarningsExact identifier
spl id: 9a42f787-2d06-4cba-b74c-8bc89aabda28
spl set id: ca302b01-0a5e-4ccb-96ba-86a7a774199b

Reported adverse events (FAERS/openFDA)#

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