Active Ingredient(S)
(in each 5 mL teaspoonful)
Acetaminophen 160 mg
Acetaminophen Solution
FDA Label NDC 0904-7321
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Acetaminophen (NDC 0904-7321). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Use(S)
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
- skin reddening
- blisters
- rash
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
- 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
5 mL Unit Dose Cup (Acetaminophen Oral Solution Usp Major 1)
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 (Acetaminophen Oral Solution Usp Major 2)
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 Oral Solution Usp Major 3)
* Please review the disclaimer below.
