Childrens Acetaminophen

Manufacturer
We Care Distributors Inc. | PURINE PHARMA LLC
Effective date
2016-08-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:46:50

Label at a glance#

ProductChildrens Acetaminophen
Active ingredientAcetaminophen
Label structure15 sections

Indications and uses

temporarily reduces fever temporarily 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. • shake well before using • mL = milliliter • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not giv...

Label contents#

Full prescribing information#

Active Ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Acetaminophen.............................Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily reduces fever
  • temporarily 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
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 non-prescription). 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 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

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
These could be signs of a serious condition.

Keep out of the 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 accidental overdose, seek
professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical 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.
• shake well before using

• mL = milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed by a doctor

Weight (lb.)                     Age (yrs.)                     Dose (mL*)
under 24                          under 2                      ask a doctor
24-35                                 2-3                             5 mL
36-47                                 4-5                             7.5 mL
48-59                                 6-8                             10 mL
60-71                                 9-10                           12.5 mL
72-95                                 11                              15 mL

* always check with your doctor before administering medicine to your infant/child

Other information

SPL UNCLASSIFIED SECTION

  • each teaspoon (mL) contains: Sodium 3 mg
  • store between 150-300C (590-860F)
  • Protect from freezing
  • Protect from light

Inactive Ingredients

INACTIVE INGREDIENT SECTION

butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C red #40, flavor, glycerin, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, xanthan gum

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Children's Tylenol®*
Children's Pain Relief
Suspension Liquid
Cherry Flavor
For ages 2 to 11
2 FL OZ (60 mL)

image of labelimage of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN2
307668acetaminophen 32 MG/ML Oral SuspensionSCD2
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY2
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY2
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY2
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY2
307668APAP 32 MG/ML Oral SuspensionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70005-041-012020-01-31C16284748780-19d75b9d0-cfd0-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-041-01Childrens Acetaminophen1 in 1 CARTONSUSPENSION12
70005-041-01Childrens Acetaminophen60 mL in 1 BOTTLE, PLASTICSUSPENSION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-041CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [WE CARE DISTRIBUTORS INC.]2Legacy NDC, 2 package rows20160818_d073053e-5789-4bce-9246-cac0ada63c31.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70005-04170005-041-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
813fae05-a5b9-40a6-83fa-5146a2625445d073053e-5789-4bce-9246-cac0ada63c312016-08-17WarningsExact identifier
spl id: 813fae05-a5b9-40a6-83fa-5146a2625445
spl set id: d073053e-5789-4bce-9246-cac0ada63c31

Reported adverse events (FAERS/openFDA)#

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