ACETAMINOPHEN SOLUTION- acetaminophen liquid

Acetaminophen Solution by

Drug Labeling and Warnings

Acetaminophen Solution by is a Otc medication manufactured, distributed, or labeled by Patrin Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains due to:

• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• premenstrual and menstrual cramps

Temporarily reduces fever

Warnings

Liver warning

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

• an adult takes more than 6 doses in 24 hours, or greater than 4000 mg of acetaminophen, the maximum daily amount
• a child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• taken with 3 or more alcoholic drinks every day while using this product

Allergy

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

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, 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
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• if you are allergic to acetaminophen or any of the inactive ingredients of his product

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse
• redness or swelling is present

If pregnant or breastfeeding, ask a health professional before use.

Keep Out Of Reach Of Children.

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 children even if you do not notice any signs or symptoms.

Directions

• Do not take more than directed (see overdose warning)
• Use the following dosage guidelines when using this product

AGE	DOSE
Adults and children 12 years of age and over	20.3 mL (650 mg) every 4 to 6 hours; Not to exceed 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 2 to under 4 years of age	5 mL (160 mg) every 4 hours; Not to exceed 5 doses in a 24-hour period
Children under 2 years of age	Consult a doctor

Other Information

• Each 5 mL contains: sodium 2 mg
• Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• Keep tightly closed
• Protect from light
• Do not use if foil on cup is missing or torn

Inactive Ingredients

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sorbitol.

Questions Or Comments?

Call (800) 936-3088. You may also report serious side effects to this phone number.

How Supplied

• A red, cherry flavored solution supplied in the following oral dosage cups:

• NDC: 39328-031-05: 5 mL unit dose cup
• NDC: 39328-031-50: Case contains 50 unit dose cups of 5 mL (39328-031-05).
• NDC: 39328-031-99: Case contains 100 unit dose cups of 5 mL (39328-031-05).

• NDC: 39328-032-10: 10.15 mL unit dose cup
• NDC: 39328-032-50: Case contains 50 unit dose cups of 10.15 mL (39328-032-10).
• NDC: 39328-032-99: Case contains 100 unit dose cups of 10.15 mL (39328-032-10).

• NDC: 39328-034-20: 20.3 mL unit dose cup
• NDC: 39328-034-50: Case contains 50 unit dose cups of 20.3 mL (39328-034-20).
• NDC: 39328-034-99: Case contains 100 unit dose cups of 20.3 mL (39328-034-20).

SPL UNCLASSIFIED SECTION

Patrin Pharma
Skokie, IL 60076
www.patrinpharma.com

Rev 02.0424

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

Delivers 5 mL
NDC: 39328-031-05
Acetaminophen
Oral Solution USP
160 mg/5 mL
Alcohol Free
For Institutional Use Only
See Insert

Lot# xxxxxx
Exp: yyyy/mm/dd
Patrin Pharma
Skokie, IL 60076
Rev 03.0324

PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label

Delivers 10.15 mL
NDC: 39328-032-10
Acetaminophen
Oral Solution USP
325 mg/10.15 mL
Alcohol Free
For Institutional Use Only
See Insert

Lot# xxxxxx
Exp: yyyy/mm/dd
Patrin Pharma
Skokie, IL 60076
Rev 03.0324

PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label

Delivers 20.3 mL
NDC: 39328-034-20
Acetaminophen
Oral Solution USP
650 mg/20.3 mL
Alcohol Free
For Institutional Use Only
See Insert

Lot# xxxxxx
Exp: yyyy/mm/dd
Patrin Pharma
Skokie, IL 60076
Rev 03.0324

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN SOLUTION 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39328-031
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
Saccharin sodium (UNII: SB8ZUX40TY)
Sodium benzoate (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39328-031-50	5 in 1 CASE	09/27/2023
1		10 in 1 TRAY
1	NDC: 39328-031-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 39328-031-99	10 in 1 CASE	05/13/2024
2		10 in 1 TRAY
2	NDC: 39328-031-05	5 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 drug	M013	09/27/2023

ACETAMINOPHEN SOLUTION 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39328-032
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	Acetaminophen	325 mg  in 10.15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
Saccharin sodium (UNII: SB8ZUX40TY)
Sodium benzoate (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39328-032-50	5 in 1 CASE	09/27/2023
1		10 in 1 TRAY
1	NDC: 39328-032-10	10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 39328-032-99	10 in 1 CASE	05/13/2024
2		10 in 1 TRAY
2	NDC: 39328-032-10	10.15 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 drug	M013	09/27/2023

ACETAMINOPHEN SOLUTION 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39328-034
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	Acetaminophen	650 mg  in 20.3 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
Saccharin sodium (UNII: SB8ZUX40TY)
Sodium benzoate (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39328-034-50	5 in 1 CASE	10/16/2023
1		10 in 1 TRAY
1	NDC: 39328-034-20	20.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 39328-034-99	10 in 1 CASE	05/13/2024
2		10 in 1 TRAY
2	NDC: 39328-034-20	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 drug	M013	10/16/2023

Labeler - Patrin Pharma, Inc. (806841677)