ACETAMINOPHEN- acetaminophen solution 
Kesin Pharma Corporation

----------


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

ACETAMINOPHEN Oral Solution 160mg per 5mL

ACETAMINOPHEN Oral Solution
160mg per 5mL

Active Ingredients (in each 5 mL)

Acetaminophen 160 mg

PURPOSE

Pain reliever/fever reducer

USES

Temporarily relieves minor aches and pains due to:

Temporarily reduces fever

WARNINGS

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

Ask a doctor before use if the user has liver disease.
Allergy alert:
Acetaminophen may cause severe skin reactions.

Symptoms may include:

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

  • 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

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

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

Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN.

Overdose warning:

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

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

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

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

QUESTIONS OR COMMENTS?

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 Logo

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 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 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 label

ACETAMINOPHEN 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-002(NDC:84447-104)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81033-002-4040 in 1 CARTON06/30/2021
1NDC:81033-002-1010.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:81033-002-5050 in 1 CARTON06/30/2021
2NDC:81033-002-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3NDC:81033-002-3030 in 1 CARTON06/30/2021
3NDC:81033-002-2020.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4NDC:81033-002-55100 in 1 CASE06/30/2021
4NDC:81033-002-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
5NDC:81033-002-54100 in 1 CASE06/30/2021
5NDC:81033-002-1010.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
6NDC:81033-002-53100 in 1 CARTON06/30/2021
6NDC:81033-002-2020.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/30/2021
Labeler - Kesin Pharma Corporation (117447816)
Establishment
NameAddressID/FEIBusiness Operations
Kesin Pharma Corporation117447816repack(81033-002)
Establishment
NameAddressID/FEIBusiness Operations
Kesin Pharma Corporation119132647repack(81033-002)

Revised: 12/2024
Document Id: 28655b75-0302-94a1-e063-6394a90ae1dc
Set id: c5b3c78c-9148-bf69-e053-2995a90aba65
Version: 6
Effective Time: 20241203
 
Kesin Pharma Corporation