FDA.reportPublic FDA data

5mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL

Manufacturer
Kesin Pharma Corporation
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:40:40

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains due to: headaches backaches toothaches muscular aches minor pain of arthritis the common cold premenstrual and menstrual cramps sore throat flu Temporarily reduces fever

Dosage and administration

do not take more than directed (see overdose warning) Age Dose adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to excdeed 6 doses in a 24-hour period children 6 to Under 12 years of age 10.15 mL (325 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 (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period children unde...

Label contents#

Full prescribing information#

ACETAMINOPHEN Oral Solution 160mg per 5mL

SPL UNCLASSIFIED SECTION

ACETAMINOPHEN Oral Solution
160mg per 5mL

Active Ingredients (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USES

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to:

  • headaches
  • backaches
  • toothaches
  • muscular aches
  • minor pain of arthritis
  • the common cold
  • premenstrual and menstrual cramps
  • sore throat
  • flu

Temporarily reduces fever

WARNINGS

WARNINGS SECTION

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

  • adult takes more than more than 6 doses in 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 everyday while using this product

Ask a doctor before use if the user has liver disease.
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 throat is severe, persistent for more than 2 days, or is accompanied or followed by a fever,
headache, nausea, rash, or vomiting, consult a physician 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.
  • for more than 3 days for fever unless directed by a doctor
  • for more that 10 days for pain unless directed by a doctor
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

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 - STOP USE SECTION

Stop use and ask a doctor if

  • symptoms do not improve
  • new symptoms occur
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

These could be signs of a serious condition.

If Pregnant or breast-feedinging

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

Overdose warning:

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)
Age

Dose

adults and children 12 years of age and over20.3 mL (650 mg) every 4 to 6 hours not to excdeed 6 doses in a 24-hour period
children 6 to Under 12 years of age10.15 mL (325 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 under 2 years of ageconsult a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
  • keep tightly closed
  • protect from light
  • tamper evident: DO NOT use if foil on cup is missing or torn
  • a clear, grape flavored solution supplied in the following oral dosage forms:

NDC 81033-002-05: 5 mL (160mg) unit dose cup
NDC 81033-002-55: Case contains 100 unit dose cups of 5 mL (81033-002-05); packaged in a carton of 50 unit dose cups each.
NDC 81033-002-10: 10.15mL (325mg) unit dose cup
NDC 81033-002-54: Case contains 100 unit dose cups of 10.15 mL (81033-002-10); packaged in a carton of 50 unit dose cups
each.
NDC 81033-002-20: 20.3 mL (650mg) unit dose cup
NDC 81033-002-53: Case contains 100 unit dose cups of 20.3 mL (81033-002-20); packaged in a carton of 50 unit dose cups
each.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call Kesin Pharma at 1-833-537-4679. You may also report serious side effects to this phone number.

Packaged by:
Kesin Pharma
Oldsmar, FL 34677
Effective: 08/2024

Revision 01

Kesin Pharma LogoKesin Pharma Logo

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-002-05

Acetaminophen Oral Solution

160mg/5mL

Delivers160mg/5mL

Store at 68° - 77° F

LOT

EXP

PKG by Kesin Pharma

Oldsmar, FL

Alcohol, Dye, Sugar Free

For Institutional Use

5mL container label5mL container label

NDC 81033-002-10

Acetaminophen Oral Solution

160mg/5mL

Delivers 325mg/10.15mL

Store at 68° - 77° F

LOT

EXP

PKG by Kesin Pharma

Oldsmar, FL

Alcohol, Dye, Sugar Free

For Institutional Use

10.15mL container label10.15mL container label

NDC 81033-002-20

Acetaminophen Oral Solution

160mg/5mL

Delivers 650mg/20.15mL

Store at 68° - 77° F

LOT

EXP

PKG by Kesin Pharma

Oldsmar, FL

Alcohol, Dye, Sugar Free

For Institutional Use

20.3mL container label20.3mL container label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN6
307675acetaminophen 32 MG/ML Oral SolutionSCD6
307675acetaminophen 160 MG per 5 ML Oral SolutionSY6
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY6
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY6
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY6
307675APAP 32 MG/ML Oral SolutionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81033-002-312024-12-02C16284748780-11e7a6dab-16f4-a2ce-e063-dadaa90aadf75mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL
81033-002-412024-12-02C16284748780-11e7a6dab-16f4-a2ce-e063-dadaa90aadf75mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL
81033-002-512024-12-02C16284748780-11e7a6dab-16f4-a2ce-e063-dadaa90aadf75mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL
81033-002-312024-07-30C16284748780-11e7a6dab-16f4-a2ce-e063-dadaa90aadf75mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL
81033-002-412024-07-30C16284748780-11e7a6dab-16f4-a2ce-e063-dadaa90aadf75mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL
81033-002-512024-07-30C16284748780-11e7a6dab-16f4-a2ce-e063-dadaa90aadf75mL, 10.15mL, 20.3mL, ACETAMINOPHEN oral solution 160mg per 5mL, 10.15mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-002-05Acetaminophen5 mL in 1 CUP, UNIT-DOSESOLUTION56
81033-002-10Acetaminophen10.15 mL in 1 CUP, UNIT-DOSESOLUTION10.156
81033-002-20Acetaminophen20.3 mL in 1 CUP, UNIT-DOSESOLUTION20.36
81033-002-30Acetaminophen30 in 1 CARTONSOLUTION306
81033-002-40Acetaminophen40 in 1 CARTONSOLUTION406
81033-002-50Acetaminophen50 in 1 CARTONSOLUTION506
81033-002-53Acetaminophen100 in 1 CARTONSOLUTION1006
81033-002-54Acetaminophen100 in 1 CASESOLUTION1006
81033-002-55Acetaminophen100 in 1 CASESOLUTION1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-002ACETAMINOPHEN SOLUTION [KESIN PHARMA CORPORATION]6Legacy NDC, 9 package rows20241207_c5b3c78c-9148-bf69-e053-2995a90aba65.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-002-05ML - Milliliter81033-002df084a20-976d-4893-9f0f-849d2e7b51a112021-09-07
81033-002-10ML - Milliliter81033-002c1391bb6-7477-4b6b-9088-e3d4c5843aa412021-09-07
81033-002-20ML - Milliliter81033-002fa827bdc-75a9-4525-b5f0-2bd4661f862012021-09-07
81033-002-30ML - Milliliter81033-002d7d18747-ccf6-4c7c-adb1-c02ec2d074e412021-09-07
81033-002-40ML - Milliliter81033-00228471a82-9d8a-46db-909a-9c6c417310f012021-09-07
81033-002-50ML - Milliliter81033-0027c72bb51-3d41-49ee-949d-30db6a6c538d12021-09-07
81033-002-53ML - Milliliter81033-0021584efa3-0e43-4654-9a46-715327b6572412024-12-10
81033-002-54ML - Milliliter81033-00210c3e057-6d8b-478f-bb67-a76ee650b49d12024-12-10
81033-002-55ML - Milliliter81033-002cb745b34-eb89-44a4-90dd-b68ab58c0ecb12024-12-10

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81033-00281033-002-10, 81033-002-40, 81033-002-05, 81033-002-50, 81033-002-20, 81033-002-30, 81033-002-55, 81033-002-54, 81033-002-53
84447-104

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
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
POTASSIUM CITRATEEE90ONI6FFIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT

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
28655b75-0302-94a1-e063-6394a90ae1dcc5b3c78c-9148-bf69-e053-2995a90aba652024-12-03WarningsExact identifier
spl id: 28655b75-0302-94a1-e063-6394a90ae1dc
spl set id: c5b3c78c-9148-bf69-e053-2995a90aba65

Reported adverse events (FAERS/openFDA)#

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