ACETAMINOPHEN SOLUTION- acetaminophen liquid 
Patrin Pharma, Inc.

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Acetaminophen Oral Solution USP UD

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:

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

AGEDOSE
Adults and children 12 years of age and over20.3 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 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 2 to under 4 years of age5 mL (160 mg) every 4 hours
Not to exceed 5 doses in a 24-hour period
Children under 2 years of ageConsult a doctor

Other Information

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

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).

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 - 5 mL Cup Label

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 - 10.15 mL Cup Label

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

PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label
ACETAMINOPHEN SOLUTION 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39328-031
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)  
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
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:39328-031-505 in 1 CASE09/27/2023
110 in 1 TRAY
1NDC:39328-031-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:39328-031-9910 in 1 CASE05/13/2024
210 in 1 TRAY
2NDC:39328-031-055 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 drugM01309/27/2023
ACETAMINOPHEN SOLUTION 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39328-032
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen325 mg  in 10.15 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:39328-032-505 in 1 CASE09/27/2023
110 in 1 TRAY
1NDC:39328-032-1010.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:39328-032-9910 in 1 CASE05/13/2024
210 in 1 TRAY
2NDC:39328-032-1010.15 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 drugM01309/27/2023
ACETAMINOPHEN SOLUTION 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39328-034
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen650 mg  in 20.3 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:39328-034-505 in 1 CASE10/16/2023
110 in 1 TRAY
1NDC:39328-034-2020.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:39328-034-9910 in 1 CASE05/13/2024
210 in 1 TRAY
2NDC:39328-034-2020.3 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 drugM01310/16/2023
Labeler - Patrin Pharma, Inc. (806841677)

Revised: 5/2024
Document Id: 3fe345ab-3f0f-4111-afa2-d8d76ee1c410
Set id: 52ae729b-2255-420c-8db8-cabdc2b74796
Version: 1
Effective Time: 20240521
 
Patrin Pharma, Inc.