FDA.reportPublic FDA data

CHILDREN'S Acetaminophen Oral Suspension, USP

Manufacturer
Kesin Pharma Corporation | Belleview Biosciences LLC
Effective date
2026-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:47:43

Label at a glance#

ProductCHILDRENS Acetaminophen
Active ingredientACETAMINOPHEN
Label structure13 sections

Indications and uses

Temporarily reduces fever Temporarily relieves minor aches and pains due to: the common cold flu headaches sore throat toothaches

Dosage and administration

this product does not contain directions or complete warnings for adult use do not take more than directed (see overdose warning) shake well before using mL = milliliter 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 give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) Under 24 Under 2 years Ask a doctor 24 t...

Label contents#

Full prescribing information#

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
Temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headaches
  • sore throat
  • toothaches

WARNINGS

WARNINGS SECTION

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 throat is severe, persistent for more than 2 days, is accompanied
or followed by fever, headache, nausea, rash, 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 is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the your child has liver disease
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
When using this product, do not exceed the recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. 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

  • this product does not contain directions or complete warnings for adult use
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • 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 give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (mL)
Under 24Under 2 yearsAsk a doctor
24 to 352 to 3 years

5 mL

36 to 474 to 5 years7.5 mL
48 to 596 to 8 years10 mL
60 to 719 to 10 years12.5 mL
72 to 9511 years15 mL

* or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

  • each 5 mL contains: sodium: < 5 mg
  • store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]
  • protect from freezing
  • a white to off-white, cherry flavored suspension supplied in the following oral dosage forms

NDC 81033-026-05: 5 mL unit-dose cup
NDC 81033-026-38: Carton containing 30 unit-dose cups of 5 mL each.
NDC 81033-026-01: Case containing 100 unit-dose cups of 5 mL each.
NDC 81033-026-10: 10.15 mL unit-dose cup
NDC 81033-026-39: Carton containing 30 unit-dose cups of 10.15 mL each.
NDC 81033-026-02: Case containing 100 unit-dose cups of 10.15 mL each.
NDC 81033-026-20: 20.13 mL unit-dose cup
NDC 81033-026-40: Carton containing 30 unit-dose cups of 20.13 mL each.

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, cherry flavor, citric acid, glycerin, microcrystalline cellulose, potassium sorbate, purified water, sorbitol, sucralose, sucrose, and xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

Distributed by:
Kesin Pharma
Oldsmar, FL 34677
PIS-026-V01
Rev. 02/2026

Kesin Pharma LogoKesin Pharma Logo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-026-38

CHILDREN'S Acetaminophen Oral Suspension, USP

160 mg per 5 mL

30 x 5 mL Unit Dose Cups

CHILDREN'S APAP 5 mL 30 Count CartonCHILDREN'S APAP 5 mL 30 Count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-026-01

CHILDREN'S Acetaminophen Oral Suspension, USP

160 mg per 5 mL

100 UD Cups (Do Not Break Case)

CHILDREN'S APAP 5 mL 100 count CaseCHILDREN'S APAP 5 mL 100 count Case

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-026-39

CHILDREN'S Acetaminophen Oral Suspension, USP

320 mg per 10.15 mL

30 x 10.15 mL Unit Dose Cups

CHILDREN'S APAP 10.15 mL 30 count CartonCHILDREN'S APAP 10.15 mL 30 count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-026-02

CHILDREN'S Acetaminophen Oral Suspension, USP

320 mg per 10.15 mL

100 UD Cups (Do Not Break Case)

CHILDREN'S APAP 10.15 mL 100 count CaseCHILDREN'S APAP 10.15 mL 100 count Case

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 81033-026-40

CHILDREN'S Acetaminophen Oral Suspension, USP

640 mg per 20.13 mL

30 x 20.13 mL Unit Dose Cups

CHILDREN'S APAP 20.13 mL 30 count CartonCHILDREN'S APAP 20.13 mL 30 count Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN1
307668acetaminophen 32 MG/ML Oral SuspensionSCD1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY1
307668APAP 32 MG/ML Oral SuspensionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)00381033026381(17)000200(10)K0000000GTIN-14: 00381033026381
GTIN-12: 381033026381
UPC-A: 381033026381
EAN-13: 0381033026381
GTIN storage (14 digits): 00381033026381		CHILDRENSAPAP_5mL_Carton_30Ct.jpg
Data codeCode 128(01) 00381033026015 CHILDRENSAPAP_5mL_Case_100Ct.jpg
Data codeCode 128(01) 00381033026022CHILDRENSAPAP_10.15mL_Case_100Ct.jpg
Data codeCode 12800000000000000CHILDRENSAPAP_5mL_Case_100Ct.jpg, CHILDRENSAPAP_10.15mL_Case_100Ct.jpg
Data codeCode 128010038103302639811700020010K0000000CHILDRENSAPAP_10.15mL_Carton_30Ct.jpg
Data codeCode 128010038103302640411700020010K0000000CHILDRENSAPAP_20.13mL_Carton_30Ct.jpg
Data codeCode 128K0000000CHILDRENSAPAP_5mL_Carton_30Ct.jpg, CHILDRENSAPAP_10.15mL_Carton_30Ct.jpg, CHILDRENSAPAP_20.13mL_Carton_30Ct.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-026-01CHILDRENS Acetaminophen100 in 1 CASESUSPENSION1001
81033-026-02CHILDRENS Acetaminophen100 in 1 CASESUSPENSION1001
81033-026-05CHILDRENS Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION51
81033-026-10CHILDRENS Acetaminophen10.15 mL in 1 CUP, UNIT-DOSESUSPENSION10.151
81033-026-20CHILDRENS Acetaminophen20.13 mL in 1 CUP, UNIT-DOSESUSPENSION20.131
81033-026-38CHILDRENS Acetaminophen30 in 1 CARTONSUSPENSION301
81033-026-39CHILDRENS Acetaminophen30 in 1 CARTONSUSPENSION301
81033-026-40CHILDRENS Acetaminophen30 in 1 CARTONSUSPENSION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-026-01ML - Milliliter81033-026815badbb-ba6d-4650-a528-bbcdce1160c612026-05-22
81033-026-02ML - Milliliter81033-02676bab1c1-688c-46f9-88dd-9c63bd7d37f612026-05-22
81033-026-05ML - Milliliter81033-0265966282c-f74e-4cfc-b914-4e9007043db812026-05-22
81033-026-10ML - Milliliter81033-026460a25d6-a7e4-40c7-9989-10a2ccaa673e12026-05-22
81033-026-38ML - Milliliter81033-0260bf568cb-1e68-4de6-8be4-9bd4427573c312026-05-22
81033-026-39ML - Milliliter81033-0261a8eb325-d55f-44f7-a802-bf24995e442212026-05-22

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81033-02681033-026-05, 81033-026-38, 81033-026-01, 81033-026-10, 81033-026-39, 81033-026-02, 81033-026-20, 81033-026-40

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
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
WATER059QF0KO0RIACT
CITRIC ACID2968PHW8QPIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
GLYCERINPDC6A3C0OXIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SUCROSEC151H8M554IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB

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
CHILDRENS AcetaminophenCHILDRENS ACETAMINOPHENKesin Pharma Corporation4af5b025-1fd7-e825-e063-6294a90aa0052026-02-16WarningsExact identifier
ndc (package): 81033-026-20
ndc (package): 81033-026-05
ndc (package): 81033-026-01
ndc (package): 81033-026-40
ndc (package): 81033-026-10
ndc (package): 81033-026-39
ndc (package): 81033-026-02
ndc (package): 81033-026-38
ndc (product): 81033-026
ndc11 (package): 81033002639
ndc11 (package): 81033002610
ndc11 (package): 81033002605
ndc11 (package): 81033002640
ndc11 (package): 81033002601
ndc11 (package): 81033002638
ndc11 (package): 81033002620
ndc11 (package): 81033002602
spl id: 4af5ab0d-3ee5-fad5-e063-6294a90a4f41
spl set id: 4af5b025-1fd7-e825-e063-6294a90aa005

Reported adverse events (FAERS/openFDA)#

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