ACETAMINOPHEN- acetaminophen solution 
Kesin Pharma Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

DRUG FACTS

Active Ingredients (in each 5 mL)

Acetaminophen 160 mg

PURPOSE

Pain reliever/fever reducer

USES

Temporarily:

WARNINGS

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

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: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years or age unless directed by physician.

Do not use

Ask a doctor before use

Ask a doctor before use if the user has liver disease.

Ask a doctor or pharmacist before use

Do no 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.

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

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

Stop use and ask a doctor if

Stop use and ask a doctor if

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

These could be signs of a serious condition.

Keep out of reach of children.

Keep out of reach of children.

Overdose warning: 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

OTHER INFORMATION

each 5 mL contains: sodium 8 mg

store at 20 -25°C (68 -77°F)

tamper evident: DO NOT use if foil on cup is missing or torn

Alcohol Free, Dye Free, Sugar Free

INACTIVE INGREDIENTS

Citric acid, grape flavor[Ma1] , edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

grape flavor

QUESTIONS OR COMMENTS?

Call 1-833-537-4679

PRINCIPAL DISPLAY PANEL

5mL container label

10.15mL container label

20.3mL container label

NDC 81033-002-05

Acetaminophen Oral Solution

160mg/5mL

Delivers160mg/5mL

Store at 68° - 77° F

LOT

EXP

PKG by

Kesin Pharma Phoenix, AZ

Alcohol, Dye, Sugar Free

NDC 81033-002-10

Acetaminophen Oral Solution

160mg/5mL

Delivers 325mg/10.15mL

Store at 68° - 77° F

LOT

EXP

PKG by

Kesin Pharma Phoenix, AZ

Alcohol, Dye, Sugar Free

NDC 81033-002-20

Acetaminophen Oral Solution

160mg/5mL

Delivers 650mg/20.15mL

Store at 68° - 77° F

LOT

EXP

PKG by

Kesin Pharma Phoenix, AZ

Alcohol, Dye, Sugar Free

ACETAMINOPHEN 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-002
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
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81033-002-418 in 1 CASE06/30/2021
1NDC:81033-002-4040 in 1 CARTON
1NDC:81033-002-1010.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:81033-002-518 in 1 CASE06/30/2021
2NDC:81033-002-5050 in 1 CARTON
2NDC:81033-002-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3NDC:81033-002-318 in 1 CASE06/30/2021
3NDC:81033-002-3030 in 1 CARTON
3NDC: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 not finalpart34306/30/2021
Labeler - Kesin Pharma Corporation (117447816)

Revised: 7/2021
Document Id: c61a7995-69ee-6141-e053-2a95a90aae98
Set id: c5b3c78c-9148-bf69-e053-2995a90aba65
Version: 3
Effective Time: 20210701
 
Kesin Pharma Corporation