FDA.reportPublic FDA data

Acetaminophen Oral Solution USP Alcohol Free/Dye Free/Sugar Free Grape Flavored

Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:22:26

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure16 sections

Indications and uses

• for the temporary relief of minor aches and pains due to headache muscular aches backache sore throat flu the common cold toothache premenstrual and menstrual cramps • for the minor pain from arthritis • and to reduce fever

Dosage and administration

do not take more than directed (see  overdose warning ) dose product from the single dose cup the product is packaged in mL=milliliter age dose adults and children 12 years of age and over 20 mL (640 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period children 6 to under 12 years of age 10 mL (320 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 4 to under 6 years of age 7.5 mL (24...

Storage and handling

■ Each 5 mL contains: sodium 6 mg ■ store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

• for the temporary relief of minor aches and pains due to

  • headache
  • muscular aches
  • backache
  • sore throat
  • flu
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

• for the minor pain from arthritis
• and to reduce fever

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • 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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you are allergic to aetaminophen or any of the inactive ingredients of this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the user
   •  has liver disease
   •  is a child with pain of arthritis

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • adult's pain gets worse or lasts more than 10 days
  • child's pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.  (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
  • dose product from the single dose cup the product is packaged in
  • mL=milliliter
age dose
adults and children 12 years of age and over20 mL (640 mg) every 4 to 6 hours
not to exceed 6 doses in a 24-hour period
children 6 to under 12 years of age10 mL (320 mg) every 4 hours
not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age7.5 mL (240 mg) every 4 hours
not to exceed 5 doses in a 24-hour period
children 2 to under 4 years of age5 mL (160 mg) every 4 hours
not to exceed 5 doses in a 24-hour period
children under 2 years of ageconsult a doctor

Other information

STORAGE AND HANDLING SECTION

■ Each 5 mL contains: sodium 6 mg

■ store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients anhydrous citric acid, edetate disodium, flavor, glycerin, polyethylene glycol 400, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210. You may also report serious side effects to this phone number.

Distributed by:

SPL UNCLASSIFIED SECTION

PAI Pharma
Greenville,SC 29605
www.paipharma.com
R05/25

PRINCIPAL DISPLAY PANEL - 5 mL Cup

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-1047-05

Acetaminophen
Oral Solution USP
160 mg/5 mL

Pain Reliever/Fever Reducer

Alcohol Free/Dye Free/Sugar Free
Grape Flavored

Package Not Child-Resistant

Dist. by: PAI Pharma
GREENVILLE, SC 29605
See insert for drug facts

lidding for 5 mL Acetaminophen FN1047 cup
lidding for 5 mL Acetaminophen FN1047 cup

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN3
307675acetaminophen 32 MG/ML Oral SolutionSCD3
307675acetaminophen 160 MG per 5 ML Oral SolutionSY3
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY3
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY3
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY3
307675APAP 32 MG/ML Oral SolutionSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)00301211047052GTIN-14: 00301211047052
GTIN-12: 301211047052
UPC-A: 301211047052
EAN-13: 0301211047052
GTIN storage (14 digits): 00301211047052		apap-fn1047-5ml-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1047-00Acetaminophen10 in 1 TRAYSOLUTION103
0121-1047-00Acetaminophen10 in 1 CASESOLUTION103
0121-1047-05Acetaminophen5 mL in 1 CUP, UNIT-DOSESOLUTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1047-00ML - Milliliter0121-1047010e68ff-88f2-49e0-a6ec-8d3f015bd9ae12026-01-08
0121-1047-05ML - Milliliter0121-104793277862-3358-4c4c-baea-8af76ea16da312026-01-08

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
0121-10470121-1047-05, 0121-1047-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM CITRATE1Q73Q2JULRIACT

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
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmafac4e0c6-684f-45a1-99f2-de4de4017cc82025-12-11WarningsExact identifier
ndc (package): 0121-1047-05
ndc (package): 0121-1047-00
ndc (product): 0121-1047
ndc11 (package): 00121104700
ndc11 (package): 00121104705
spl id: ba8d56c1-521e-490b-a83e-ebfa2d51bd8b
spl set id: fac4e0c6-684f-45a1-99f2-de4de4017cc8

Reported adverse events (FAERS/openFDA)#

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