Acetaminophen Oral Solution Usp - Major

Acetaminophen Oral Solution Usp - Major
SPL v14
SPL
SPL Set ID 32ea1230-f9ae-46b0-910e-05cd187cee34
Route
ORAL
Published
Effective Date 2023-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate Sorbitol Sucrose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-05
Description

(in each 5 mL teaspoonful) Acetaminophen 160 mg .................Pain reliever/fever reducer

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

(in each 5 mL teaspoonful) Acetaminophen 160 mg .................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.



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


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

Distributed By:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

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.

Active Ingredient(s)

(in each 5 mL teaspoonful)

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

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

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.

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 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

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

Structured Label Content

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

Purpose

Pain reliever/fever reducer

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.



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


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 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

Distributed By: (Distributed by:)

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Other Information (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.

Active Ingredient(s) (Active ingredient(s))

(in each 5 mL teaspoonful)

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

Inactive Ingredients (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? (Questions or comments?)

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

R11/22

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Principal Display Panel 5 Ml Unit Dose Cup (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 20.3 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

Principal Display Panel 10.15 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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:24.999128 · Updated: 2026-03-14T23:07:10.032470