Acetaminophen by Major Pharmaceuticals ACETAMINOPHEN solution

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

(in each 5 mL teaspoonful)

Acetaminophen 160 mg .................Pain reliever/fever reducer

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:

•  adult takes more than 6 doses 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 every day 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: 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.

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 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
•  a red, cherry flavored solution supplied in the following oral dosage forms:

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

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

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7319(NDC:0121-0657)
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, 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
Color	red ((clear, red liquid))	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7319-70	10 in 1 CASE	06/05/2023
1		10 in 1 TRAY
1	NDC: 0904-7319-41	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	06/05/2023

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7320
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, 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
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7320-71	10 in 1 CASE	06/05/2023
1		10 in 1 TRAY
1	NDC: 0904-7320-02	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	06/05/2023

ACETAMINOPHEN 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7321
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, 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
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7321-76	10 in 1 CASE	06/05/2023
1		10 in 1 TRAY
1	NDC: 0904-7321-03	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	06/05/2023

Labeler - Major Pharmaceuticals (191427277)