FDA.reportPublic FDA data

Acetaminophen Oral Suspension

Manufacturer
Precision Dose, Inc.
Effective date
2025-02-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:55:47

Label at a glance#

ProductAcetaminophen
Active ingredientAcetaminophen
Label structure13 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. do not take more than directed (see overdose warning ) shake well before using find the right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not take more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL 3...

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 325 mg/10.15 mL

650 mg/20.3 mL

For Hospital Use Only

LI1650 Rev. 10/24

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

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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 the user has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the user 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 10 days (for adults) or 5 days (for children)
  • 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.

  • do not give this product to children for pain of arthritis unless directed by a doctor

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.

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 for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use as directed per healthcare professional.
  • do not take more than directed (see overdose warning)
  • shake well before using
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not take 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
Over 96Adults and children 12 years and over20 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, 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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-397-9228

SPL UNCLASSIFIED SECTION

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

How Supplied

SPL UNCLASSIFIED SECTION

NDC 68094-042-58
2.5 mL per unit dose ENFit syringe
Fifty (50) syringes per shipper

NDC 68094-038-58
5 mL per unit dose ENFit syringe
Fifty (50) syringes per shipper

NDC 68094-130-58
2.5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-231-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-231-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-231-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-330-61
10.15 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-330-62
10.15 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-030-62
20.3 mL per unit dose cup
Thirty (30) cups per shipper

SPL UNCLASSIFIED SECTION

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

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

LI1650 Rev. 10/24

PRINCIPAL DISPLAY PANEL - 2.5 mL Syringe Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACETAMINOPHEN ORAL SUSPENSION

80 mg / 2.5 mL Delivers 2.5 mL

Store at 20-25°C (68-77°F)

Hospital Use Only • Alcohol Free

Aspirin Free • Gluten Free • Ibuprofen Free

For Oral Use Only

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

PRINCIPAL DISPLAY PANEL - 2.5 mL Syringe Label
PRINCIPAL DISPLAY PANEL - 2.5 mL Syringe Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN6
307668acetaminophen 32 MG/ML Oral SuspensionSCD6
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY6
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY6
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY6
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY6
307668APAP 32 MG/ML Oral SuspensionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-130-01Acetaminophen2.5 mL in 1 SYRINGE, PLASTICSUSPENSION2.56
68094-130-58Acetaminophen10 in 1 BAGSUSPENSION106
68094-130-58Acetaminophen5 in 1 CASESUSPENSION56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-130ACETAMINOPHEN SUSPENSION [PRECISION DOSE, INC.]6Current NDC, 3 package rows20250224_b16e5dcf-b290-4ff2-a150-4b875647ec9a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-130-01ML - Milliliter68094-130f637634c-59aa-43f3-93db-01a81c8558d712023-09-05
68094-130-58ML - Milliliter68094-130bf9ed973-52b1-4e34-82fa-51554a6abc5812023-09-05
0113-0212-26ML - Milliliter0113-02127b84616a-a959-430b-a063-a226fce4c98d12013-12-02

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
68094-13068094-130-01, 68094-130-58
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

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
AcetaminophenACETAMINOPHENPrecision Dose, Inc.b16e5dcf-b290-4ff2-a150-4b875647ec9a2025-02-19WarningsExact identifier
ndc (package): 68094-130-01
ndc (package): 68094-130-58
ndc (product): 68094-130
ndc11 (package): 68094013001
ndc11 (package): 68094013058
spl id: c1901824-e0d1-4a91-83c5-fc2737cb32ea
spl set id: b16e5dcf-b290-4ff2-a150-4b875647ec9a
Good Sense Childrens Pain and FeverACETAMINOPHENL. Perrigo Companyc6b79501-d08b-4430-9545-70da5f5459752024-12-03WarningsExact identifier
ndc (product): 0113-0212

Reported adverse events (FAERS/openFDA)#

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