DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Anhydrous Citric Acid Methylparaben Propylparaben Propylene Glycol Sorbitol Ammonium Glycyrrhizate Potassium Citrate Water Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-06-30

Medication Information

Purpose

Pain reliever/fever reducer

Description

ACETAMINOPHEN Oral Solution 160mg per 5mL

Uses

Temporarily relieves minor aches and pains due to:

headaches
backaches
toothaches
muscular aches
minor pain of arthritis
the common cold
premenstrual and menstrual cramps
sore throat
flu

Temporarily reduces fever

Warnings

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

adult takes more than more than 6 doses in in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks everyday while using this product

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

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, or is accompanied or followed by a fever,

headache, nausea, rash, or vomiting, consult a physician promptly.

Directions

do not take more than directed (see overdose warning)

Age	Dose
adults and children 12 years of age and over	20.3 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 age	10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age	7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children under 2 years of age	consult a doctor

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.

Other Information

store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
keep tightly closed
protect from light
tamper evident: DO NOT use if foil on cup is missing or torn
a clear, grape flavored solution supplied in the following oral dosage forms:

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.

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.

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

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

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

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

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.

Keep Out of Reach of Children.

KEEP OUT OF REACH OF CHILDREN.

If Pregnant Or Breast Feedinging

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

Active Ingredients (in Each 5 Ml)

Acetaminophen 160 mg

Acetaminophen Oral Solution 160mg Per 5ml

ACETAMINOPHEN Oral Solution

160mg per 5mL

Structured Label Content

Uses (USES)

Temporarily relieves minor aches and pains due to:

headaches
backaches
toothaches
muscular aches
minor pain of arthritis
the common cold
premenstrual and menstrual cramps
sore throat
flu

Temporarily reduces fever

Purpose (PURPOSE)

Pain reliever/fever reducer

Warnings (WARNINGS)

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

adult takes more than more than 6 doses in in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks everyday while using this product

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

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, or is accompanied or followed by a fever,

headache, nausea, rash, or vomiting, consult a physician promptly.

Directions (DIRECTIONS)

do not take more than directed (see overdose warning)

Age	Dose
adults and children 12 years of age and over	20.3 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 age	10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age	7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children under 2 years of age	consult a doctor

Do Not Use (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.

Other Information (OTHER INFORMATION)

store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
keep tightly closed
protect from light
tamper evident: DO NOT use if foil on cup is missing or torn
a clear, grape flavored solution supplied in the following oral dosage forms:

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.

Overdose Warning: (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.

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments? (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

Principal Display Panel (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

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

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

Stop Use and Ask A Doctor If (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.

Keep Out of Reach of Children. (Keep out of reach of children.)

KEEP OUT OF REACH OF CHILDREN.

If Pregnant Or Breast Feedinging (If Pregnant or breast-feedinging)

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

Active Ingredients (in Each 5 Ml) (Active Ingredients (in each 5 mL))

Acetaminophen 160 mg

Acetaminophen Oral Solution 160mg Per 5ml (ACETAMINOPHEN Oral Solution 160mg per 5mL)

ACETAMINOPHEN Oral Solution

160mg per 5mL

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMMONIUM GLYCYRRHIZATE", "unii": "3VRD35U26C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CITRATE", "unii": "EE90ONI6FF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "Temporarily relieves minor aches and pains due to: headaches backaches toothaches muscular aches minor pain of arthritis the common cold premenstrual and menstrual cramps sore throat flu Temporarily reduces fever", "PURPOSE": "Pain reliever/fever reducer", "WARNINGS": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than more than 6 doses in in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Ask a doctor before use if the user has liver disease. 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, or is accompanied or followed by a fever, headache, nausea, rash, or vomiting, consult a physician promptly.", "DIRECTIONS": "do not take more than directed (see overdose warning) Age Dose adults and children 12 years of age and over 20.3 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 age 10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 4 to under 6 years of age 7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period children under 2 years of age consult a doctor", "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.", "OTHER INFORMATION": "store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. keep tightly closed protect from light tamper evident: DO NOT use if foil on cup is missing or torn a clear, grape flavored solution supplied in the following oral dosage forms: 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.", "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.", "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", "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 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 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", "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.", "Keep out of reach of children.": "KEEP OUT OF REACH OF CHILDREN.", "If Pregnant or breast-feedinging": "If pregnant or breast-feeding, ask a health professional before use.", "Active Ingredients (in each 5 mL)": "Acetaminophen 160 mg", "ACETAMINOPHEN Oral Solution 160mg per 5mL": "ACETAMINOPHEN Oral Solution 160mg per 5mL"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information