Children Acetaminophen Oral Solution

Manufacturer
VERITYRX. LLC
Effective date
2025-11-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:20:31

Label at a glance#

ProductChildren Acetaminophen Oral Solution
Active ingredientACETAMINOPHEN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (per 5 mL teaspoonful)

Acetaminophen 160 mg

OTC - PURPOSE SECTION

Purpose

Pain Reliever/Fever Reducer

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

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 thoat 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 acetaminophe or any of the inactive indreadients in this product.

Ask a doctor before use if your child hasliver disease.

Ask a doctor before use if your child istaking the blood thinning drug warfarin.

When using this product: Do not exceed recommended dose.

Stop use and ask a doctor if

  • 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.

INDICATIONS & USAGE SECTION

Uses

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Paoison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed
  • find dose in chart below
  • if possible, use weight to dose, otherwise use age
  • dosage may be repeasted every 4 hours, or as directed by a doctor
  • do not give more than 5 doses in 24 hours
Weight (lbs)under 2424-3536-4748-5960-7172-95
Age (years)under 22 to 34 to 56 to 89 to 1011
Dosage Teaspoonful (tsp)consult Physician1 tsp (5 mL)1 1/2 tsp (7.5 mL)2 tsp (10 mL)2 1/2 tsp (12.5 mL)3 tsp (15 mL)

INACTIVE INGREDIENT SECTION

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

RECENT MAJOR CHANGES SECTION

Changed Uses to:

temporarily relieves minor aches and pains due to

  • headache
  • toothache
  • the common cold
  • temporarily reduces fever
  • flu
  • sore throat

Removed 12 years to adult from dosage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Child AcetaminophenChild Acetaminophen

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN1
307675acetaminophen 32 MG/ML Oral SolutionSCD1
307675acetaminophen 160 MG per 5 ML Oral SolutionSY1
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY1
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY1
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY1
307675APAP 32 MG/ML Oral SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00383939001028(21)02485001(10)024850(17)260322GTIN-14: 00383939001028
GTIN-12: 383939001028
UPC-A: 383939001028
EAN-13: 0383939001028
GTIN storage (14 digits): 00383939001028
Child Acetaminophen 001002 (002).jpg

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
83939-0010-1Children Acetaminophen Oral Solution1 mL in 1 CUP, UNIT-DOSELIQUID11
83939-0010-2Children Acetaminophen Oral Solution10 in 1 BOX, UNIT-DOSELIQUID101
83939-0010-2Children Acetaminophen Oral Solution1 mL in 1 CUP, UNIT-DOSELIQUID11
83939-0010-3Children Acetaminophen Oral Solution1 mL in 1 CUP, UNIT-DOSELIQUID11
83939-0010-3Children Acetaminophen Oral Solution40 in 1 BOX, UNIT-DOSELIQUID401
83939-0010-4Children Acetaminophen Oral Solution50 in 1 BOX, UNIT-DOSELIQUID501
83939-0010-4Children Acetaminophen Oral Solution1 mL in 1 CUP, UNIT-DOSELIQUID11
83939-0010-5Children Acetaminophen Oral Solution1 mL in 1 CUP, UNIT-DOSELIQUID11
83939-0010-5Children Acetaminophen Oral Solution100 in 1 BOX, UNIT-DOSELIQUID1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7014-16ML - Milliliter0904-7014fde87ac6-229a-4749-8cae-65366a4b0e4f12019-11-12
0904-7014-20ML - Milliliter0904-7014a0a63714-8c01-42e1-ade2-5f84780549ab12019-11-12

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
83939-001083939-0010-1, 83939-0010-2, 83939-0010-3, 83939-0010-4, 83939-0010-5
0904-7014

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Children Acetaminophen Oral SolutionACETAMINOPHENVERITYRX. LLC42a17f54-7851-84fb-e063-6394a90a9ec12025-11-02WarningsExact identifier
ndc (package): 83939-0010-1
ndc (package): 83939-0010-3
ndc (package): 83939-0010-4
ndc (package): 83939-0010-5
ndc (package): 83939-0010-2
ndc (product): 83939-0010
ndc11 (package): 83939001004
ndc11 (package): 83939001002
ndc11 (package): 83939001001
ndc11 (package): 83939001003
ndc11 (package): 83939001005
spl id: 42a17f6b-4652-cb84-e063-6294a90ae477
spl set id: 42a17f54-7851-84fb-e063-6394a90a9ec1
Children Acetaminophen Oral SolutionACETAMINOPHENMAJOR PHARMACEUTICALScfca5147-f390-40bd-8f13-c5b3b8d1c5b02025-06-09WarningsExact identifier
ndc (product): 0904-7014

Reported adverse events (FAERS/openFDA)#

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