Acetaminophen by Kesin Pharma Corporation ACETAMINOPHEN solution

Acetaminophen by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTS

Active Ingredients (in each 5 mL)

Acetaminophen 160 mg

PURPOSE

Pain reliever/fever reducer

USES

Temporarily:

• reduces fever
• relieves minor aches and pains due to:
• the common cold
• flu
• headache
• sore throat
• toothache

WARNINGS

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

• adult takes more than more than 5 doses in in 24 hours, which is the maximum daily amount for this product
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has more alcoholic drinks everyday while using this product

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: 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

• do not take more than directed (see overdose warning)
• do not take more than 5 doses in any 24-hour period
• dose as follows or as directed by doctor:
• take only with dosing cup provided
• adults and children 12 years of age and older: 20 mL (640 mg) in dosing cup every 6 hours
• children under 12 years of age: ask a doctor
• this product does not contain directions or complete warnings for use

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

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81033-002
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
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
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-002-41	8 in 1 CASE	06/30/2021
1	NDC: 81033-002-40	40 in 1 CARTON
1	NDC: 81033-002-10	10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 81033-002-51	8 in 1 CASE	06/30/2021
2	NDC: 81033-002-50	50 in 1 CARTON
2	NDC: 81033-002-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3	NDC: 81033-002-31	8 in 1 CASE	06/30/2021
3	NDC: 81033-002-30	30 in 1 CARTON
3	NDC: 81033-002-20	20.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/30/2021

Labeler - Kesin Pharma Corporation (117447816)