Active Ingredient (In Each 15 Ml-Teaspoonful)
Acetaminophen 500 mg
Acetaminophen Extra Strength Solution
FDA Label NDC 73564-817
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aldama Pharmaceuticals, Inc for the product Acetaminophen Extra Strength (NDC 73564-817). 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 (in each 15 ml-teaspoonful), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, 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
Uses
- Temporarily relieves minor aches and pains
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Severe liver damage may occur if:you take
- more than 8 tablespoonfuls (4,000mg of acetaminophen) in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using the 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.
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.
Otc - Ask Doctor
Ask a doctor before use if your childhas liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor before use if you have taking the blood thinning drug warfarin.
Otc - When Using
When using this product do not exceed recommended dose
Otc - Stop Use
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or conbtact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms
If Pregnant Or Breast-Feeding
ask a health professional before use
Dosage & Administration
Directions
- do not take more than directed
| Age | DOSE |
| Adults and children 12 years of age and older | Take 1 to 2 tablespoonfuls every 4 to 6 hours as needed, not more than 6 Tablespoonfuls in 24 hours |
| Children under 12 years | Do not use |
Other Safety Information
Other information
- store at room temperature between 15-30°C (59-86°F)
- protect from freezing
- protect from light
- TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing
Inactive Ingredient
Inactive Ingredient
artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Otc - Questions
Question or Comments?
call 305-592-9216 or [email protected]
* Please review the disclaimer below.
