FDA.reportPublic FDA data

Childrens Pain Relief

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2025-09-18
Label type
Human OTC Drug Label
Version
5
Source
full-release
Hydrated at
2026-06-01 01:14:15

Label at a glance#

ProductChildrens Pain Relief
Active ingredientACETAMINOPHEN
Label structure14 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning) find right dose on chart below. If possible, use weight to dose; otherwise, use age chew before swallowing; this product will soften in mouth for ease of chewing repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets)*...

Storage and handling

store at 20° to 25°C (68° to 77°F). Avoid high humidity. Tamper Evident: Do not use if carton is open or if printed seal on blister is broken or missing.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION


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

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 dosage.

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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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)
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

Weight (lb)
Age (yr)
Dose (tablets)*
* or as directed by a doctor
under 24
under 2 years
ask a doctor
24-35
2-3 years
1 tablet
36-47
4-5 years
1½ tablets
48-59
6-8 years
2 tablets
60-71
9-10 years
2½ tablets
72-95
11 years
3 tablets

Other information

STORAGE AND HANDLING SECTION


  • store at 20° to 25°C (68° to 77°F). Avoid high humidity.
  • Tamper Evident: Do not use if carton is open or if printed seal on blister is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.


Questions or comments?

Call 1-855-274-4122



* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Chewables.

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN



Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-766-76
Ages 2-11
Children's Pain Relief
Acetaminophen 160 mg
Pain reliever/Fever reducer

 

  • Aspirin Free                         
  • Ibuprofen Free

 


Bubblegum Flavor

Compare to the active ingredient in
Children's Tylenol® Chewables*
24
Chewable Tablets



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313820acetaminophen 160 MG Chewable TabletPSN5
313820acetaminophen 160 MG Chewable TabletSCD5
313820APAP 160 MG Chewable TabletSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-766-74Childrens Pain Relief6 in 1 BLISTER PACKTABLET, CHEWABLE65
58602-766-76Childrens Pain Relief4 in 1 CARTONTABLET, CHEWABLE45

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
58602-76658602-766-74, 58602-766-76

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
SILICON DIOXIDEETJ7Z6XBU4IACT
COPOVIDONE K25-31D9C330MD8BIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
D&C RED NO. 272LRS185U6KIACT
D&C RED NO. 302S42T2808BIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
ETHYLCELLULOSE (4 MPA.S)KC5472WRJKIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT

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 ReliefACETAMINOPHENAurohealth LLC49a740ec-8ed4-4c76-b2d0-c13651bafa5e2025-09-18WarningsExact identifier
ndc (package): 58602-766-74
ndc (package): 58602-766-76
ndc (product): 58602-766
ndc11 (package): 58602076676
ndc11 (package): 58602076674
spl id: 2a27d914-7e1d-405e-a678-5eda83a216f6
spl set id: 49a740ec-8ed4-4c76-b2d0-c13651bafa5e

Reported adverse events (FAERS/openFDA)#

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