ACETAMINOPHEN- acetaminophen solution 
Major Pharmaceuticals

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.

----------

Acetaminophen Oral Solution USP - Major

Active ingredient(s)

(in each 5 mL teaspoonful)

Acetaminophen 160 mg 

Purpose

Pain reliever/fever reducer

Use(s)

temporarily relieves minor aches and pains due to:

temporarily reduces fever

Warnings

Liver warningThis 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: 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 this product

Ask a doctor before use if the user has  liver disease

Ask a doctor or pharmacist before use if the user is 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

If pregnant or breast-feeding,

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.

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

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

NDC 0904-7319-41: 5 mL unit dose cup, in a tray of ten cups.

NDC 0904-7320-02: 10.15 mL unit dose cup, in a tray of ten cups.

NDC 0904-7321-03: 20.3 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

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

Questions or comments?

Call 1-800-845-8210. You may also report serious side effects to this phone number.

R11/22

Distributed by:

MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup

MAJOR®

NDC 0904-7319-41

Acetaminophen Oral Solution USP

160 mg/ 5 mL

ALCOHOL FREE

Delivers 5 mL  • See insert

For Institutional Use Only

MAJOR®PHARMACEUTICALS
Indianapolis, IN 46268

F0657C051022

5 mL unit dose cup

PRINCIPAL DISPLAY PANEL - 10.15 mL Unit Dose Cup

MAJOR®

NDC 0904-7320-02

Acetaminophen Oral Solution USP

325 mg/ 10.15 mL

Alcohol Free

Delivers 10.15 mL  • See insert

For Institutional Use Only

MAJOR®PHARMACEUTICALS
Indianapolis, IN 46268

F0657C111022

10.15 mL unit dose cup

PRINCIPAL DISPLAY PANEL - 20.3 mL Unit Dose Cup

MAJOR®

NDC 0904-7321-03

Acetaminophen Oral Solution USP

650 mg/ 20.3 mL

Alcohol Free

Delivers 20.3 mL  • See insert

For Institutional Use Only

MAJOR®PHARMACEUTICALS
Indianapolis, IN 46268

F0657C211022

20.3 mL unit dose cup
ACETAMINOPHEN 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7319(NDC:0121-0657)
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Colorred ((clear, red liquid)) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7319-7010 in 1 CASE06/05/2023
110 in 1 TRAY
1NDC:0904-7319-415 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 finalpart34306/05/2023
ACETAMINOPHEN 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7320
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7320-7110 in 1 CASE06/05/2023
110 in 1 TRAY
1NDC:0904-7320-0210.15 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 not finalpart34306/05/2023
ACETAMINOPHEN 
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7321
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7321-7610 in 1 CASE06/05/2023
110 in 1 TRAY
1NDC:0904-7321-0320.3 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 finalpart34306/05/2023
Labeler - Major Pharmaceuticals (191427277)

Revised: 6/2023
Document Id: 634a56fd-ad5a-4a3f-a9d0-c73beb8f9cec
Set id: 32ea1230-f9ae-46b0-910e-05cd187cee34
Version: 10
Effective Time: 20230613
 
Major Pharmaceuticals