Acetaminophen
- Dosage form
- SOLUTION
- Labeler
- Major Pharmaceuticals
- Label updated
- 2025-01-09
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN
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
[Image in the official label — see DailyMed source]
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
[Image in the official label — see DailyMed source]
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
[Image in the official label — see DailyMed source]
DailyMed Set ID: 32ea1230-f9ae-46b0-910e-05cd187cee34 · Version 14
NDC: 0904-7319, 0904-7320, 0904-7321