FDA.reportPublic FDA data

CHILDREN'S ACETAMINOPHEN ORAL SUSPENSION

Manufacturer
Precision Dose Inc.
Effective date
2022-09-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:53:23

Label at a glance#

ProductChildrens Acetaminophen
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

use as directed per healthcare professional this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning ) shake cups well before using mL = milliliter 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 Weight (lb) Age (yr) Dos...

Storage and handling

each 5 mL contains: sodium 3 mg store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Grape Flavor

80 mg/2.5 mL  160 mg/5 mL

For Hospital Use Only

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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 has ever had an allergic reaction to this product or any of its ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose (see overdose warning)

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use as directed per healthcare professional
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see overdose warning)
  • shake cups well before using
  • mL = milliliter
  • 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
Weight (lb)Age (yr)Dose (mL)*
under 24under 2 yearsask a doctor
24-352-3 years5 mL
36-474-5 years7.5 mL
48-596-8 years10 mL
60-719-10 years12.5 mL
72-9511 years15 mL

* or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

SPL UNCLASSIFIED SECTION

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

How Supplied

HOW SUPPLIED SECTION

NDC 68094-586-58
2.5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-587-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper

SPL UNCLASSIFIED SECTION

Distributed By
Perrigo Company
Allegan, MI 49010

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

OTC - QUESTIONS SECTION

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

SPL UNCLASSIFIED SECTION

LI950    Rev. 02/22

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68094-587-59

PrecisionDose ™

Children's ACETAMINOPHEN
Oral Suspension
160 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

Principal Display Panel - 5 mL Cup Label
Principal Display Panel - 5 mL Cup Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-587-58ML - Milliliter68094-58714529737-7c59-46b4-8359-299a85dd496112014-06-03
68094-587-59ML - Milliliter68094-58799afddc2-b1ef-479d-8165-05285174dd2a12014-06-03
68094-587-61ML - Milliliter68094-587e15c6260-04f1-4480-8f82-b7e08cfd98f412014-06-03
68094-587-62ML - Milliliter68094-587917251eb-e7b2-485c-b293-37cb8362267512014-06-03
0113-0212-26ML - Milliliter0113-02127b84616a-a959-430b-a063-a226fce4c98d12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
AcetaminophenACTIVE MOIETY362O9ITL9D1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSL1
butylparabenINACTIVE INGREDIENT3QPI1U3FV81
calcium sulfateINACTIVE INGREDIENTWAT0DDB5051
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS3111
carrageenanINACTIVE INGREDIENT5C69YCD2YJ1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U1
D&C red no. 33INACTIVE INGREDIENT9DBA0SBB0L1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBD1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
high fructose corn syrupINACTIVE INGREDIENTXY6UN3QB6S1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU1
sodium phosphate, tribasicINACTIVE INGREDIENTA752Q30A6X1
sorbitolINACTIVE INGREDIENT506T60A25R1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68094-58768094-587-58, 68094-587-59, 68094-587-62, 68094-587-61
0113-0212

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
anhydrous citric acidXF417D3PSLIACT
butylparaben3QPI1U3FV8IACT
calcium sulfate, unspecified formWAT0DDB505IACT
carrageenan5C69YCD2YJIACT
D&C red no. 339DBA0SBB0LIACT
FD&C blue no. 1H3R47K3TBDIACT
glycerinPDC6A3C0OXIACT
high fructose corn syrupXY6UN3QB6SIACT
microcrystalline celluloseOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
propylene glycol6DC9Q167V3IACT
water059QF0KO0RIACT
sodium benzoateOJ245FE5EUIACT
sorbitol506T60A25RIACT
sodium phosphate, tribasicA752Q30A6XIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
calcium sulfateCALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
6 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii+route+dosage form
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
sodium phosphate, tribasicSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
2 equally ranked IID candidates
calcium sulfateCALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
6 equally ranked IID candidates
high fructose corn syrupHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION / ORAL20000 mgExact identifier — unii+route+dosage form
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
calcium sulfateCALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii+route
6 equally ranked IID candidates
sodium phosphate, tribasicSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
2 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
butylparabenBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
calcium sulfateCALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
6 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
calcium sulfateCALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
6 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
D&C red no. 33D&C RED NO. 339DBA0SBB0LSUSPENSION / ORAL0.13 mg/5mlExact identifier — unii+route+dosage form
sorbitolSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
calcium sulfateCALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
6 equally ranked IID candidates

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
Good Sense Childrens Pain and FeverACETAMINOPHENL. Perrigo Companyc6b79501-d08b-4430-9545-70da5f5459752024-12-03WarningsExact identifier
ndc (product): 0113-0212
12821a78-efe1-49c8-a754-58958091cdfab493111d-1571-459b-a239-80d44e0971c32022-10-14WarningsExact identifier
spl set id: b493111d-1571-459b-a239-80d44e0971c3

Reported adverse events (FAERS/openFDA)#

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