FDA.reportPublic FDA data

Childrens Acetaminophen Liquid

Manufacturer
We Care Distributor Inc. | PURINE PHARMA LLC
Effective date
2016-10-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:47:33

Label at a glance#

ProductChildrens Acetaminophen Liquid
Active ingredientAcetaminophen
Label structure9 sections

Dosage and administration

this product does not contain directions or complete warnings for adult use. Shake well before using mL = mililliter find right dose on chart below. if possible, use weight to dose; otherwise use age 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             U...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Acetaminophen 160 mg (in each 5 mL)

OTC - PURPOSE SECTION

Purpose: Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

temporarily:

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

WARNINGS SECTION

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

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.

OTC - DO NOT USE SECTION

Do not use

  • with any other drug containing acetaminophen (prescription or non-prescription). if you are not sure wheather 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 or 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 for more than 5 days
  • fever gets worse or lasts for more than 3 days

These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use.
  • Shake well before using
  • mL = mililliter
  • find right dose on chart below. if possible, use weight to dose; otherwise use age
  • 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                 5mL

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

OTHER SAFETY INFORMATION

  • each 5 mL contains: sodium 7 mg
  • store between 15°-30°C (59°-86°F)
  • protect from freezing
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C red no. 40, flavor, glycerin, PEG 400, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®.

Children Acetaminophen Elixir - CherryChildren Acetaminophen Elixir - Cherry

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
70005-048-012020-01-31C16284748780-19d75b9d0-098b-f424-e053-dadaa90a57ceChildren's Acetaminophen Elixir

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-048-01Childrens Acetaminophen Liquid60 mL in 1 BOTTLELIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-048CHILDRENS ACETAMINOPHEN LIQUID (ACETAMINOPHEN) LIQUID [WE CARE DISTRIBUTOR INC.]2Legacy NDC, 1 package rows20161013_b23302bd-170e-46ec-8f4f-524c378fa405.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70005-04870005-048-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT

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
40bc5371-feeb-4620-8e7d-5c8e165d5257b23302bd-170e-46ec-8f4f-524c378fa4052016-10-12WarningsExact identifier
spl id: 40bc5371-feeb-4620-8e7d-5c8e165d5257
spl set id: b23302bd-170e-46ec-8f4f-524c378fa405

Reported adverse events (FAERS/openFDA)#

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