Otc - Active Ingredient
Acetaminophen 500 mg
Major Extra Strength Acetaminophen Liquid
FDA Label NDC 0904-7532
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 Major Extra Strength Acetaminophen Liquid (NDC 0904-7532). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, otc - 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
Otc - Purpose
Pain Relever/Fever Reducer
Indications & Usage
USES
- temporarily relieves minor aches and pains due to
- headache
- toothache
- muscular aches
- the common cold
- backache
- minor pain from arthritis
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Warnings
Liver Warning: This product contains acetaminophen. The maxium daily dose of this product is 90 mL in 24 hours. Severe liver damage may occur if you take
- more than 120 ml (4,000 mg of acetaminophen) in 24 hours
- with other drusg containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
- if a skin reaction occurs, stop use and seek medical help right away.
Allergy Alert: Acetaminophen may cause skin reactions. Symptoms may include:
Otc - 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
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have liver disease.
Ask a doctor before use if you are taking the blood thinning drug warafin
When using this product: Do not exceed recommeneded dose.
Otc - Stop Use
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever get worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Dosage & Administration
Directions
- do not take more than directed
- mL = mililiters
- measure only with dosing cup provided
- do not use any other dosing service
- Adults and children 12 years and over:
- take 15 to 30 mL every 4 to 6 hours as needed
- do not take more than 90 mL in 24 hours, unless directed by a doctor
- Children under 12 years: do not use
Inactive Ingredient
Inactive ingredients: artificail and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Otc - Questions
Questions or comments? 866-595-5598
Package Label.Principal Display Panel
Major (Major)
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