CHILDRENS ACETAMINOPHEN suspension

CHILDRENS Acetaminophen by

Drug Labeling and Warnings

CHILDRENS Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Kesin Pharma Corporation, Belleview Biosciences LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

PURPOSE

Pain Reliever/Fever Reducer

USES

Temporarily reduces fever
Temporarily relieves minor aches and pains due to:

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

WARNINGS

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

• 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

• 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.

Keep out of reach of children.

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

• 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 to 35	2 to 3 years	5 mL
36 to 47	4 to 5 years	7.5 mL
48 to 59	6 to 8 years	10 mL
60 to 71	9 to 10 years	12.5 mL
72 to 95	11 years	15 mL

* or as directed by a doctor

Other 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

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

Questions or comments?

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

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

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

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)

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

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)

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

INGREDIENTS AND APPEARANCE

CHILDRENS ACETAMINOPHEN 
childrens acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81033-026
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
WATER (UNII: 059QF0KO0R)
CITRIC ACID (UNII: 2968PHW8QP)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
GLYCERIN (UNII: PDC6A3C0OX)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-026-38	30 in 1 CARTON	02/27/2026
1	NDC: 81033-026-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 81033-026-01	100 in 1 CASE	02/27/2026
2	NDC: 81033-026-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3	NDC: 81033-026-39	30 in 1 CARTON	02/27/2026
3	NDC: 81033-026-10	10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4	NDC: 81033-026-02	100 in 1 CASE	02/27/2026
4	NDC: 81033-026-10	10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
5	NDC: 81033-026-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product	02/27/2026
6	NDC: 81033-026-10	10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product	02/27/2026
7	NDC: 81033-026-40	30 in 1 CARTON	02/27/2026
7	NDC: 81033-026-20	20.13 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
8	NDC: 81033-026-20	20.13 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product	02/27/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/27/2026

Labeler - Kesin Pharma Corporation (117447816)

Establishment
Name	Address	ID/FEI	Business Operations
Kesin Pharma Corporation		117447816	label(81033-026) , pack(81033-026)

Establishment
Name	Address	ID/FEI	Business Operations
Belleview Biosciences LLC		131968803	manufacture(81033-026)