Active Ingredients
Acetaminophen 325 mg
Regular Strength Pain Relief
FDA Label NDC 50090-5148
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Regular Strength Pain Relief (NDC 50090-5148). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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 10 tablets
in 24 hours. Severe liver damage may occur if you take:
- more than 12 tablets (4,000 mg of acetaminophen)
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using
- skin reddening
- blisters
- rash
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptom occur
- redness or swelling is present
in 24 hours
this product
Allergy alert: acetaminophen may cause severe skin
reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop use and ask a doctor if
These could be signs of a serious condition.
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 right away.
Quick medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed
- adults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours
- children under 12 years: ask a doctor
Other Information
- store at 20⁰C-25⁰C (68⁰F-77⁰F)
Inactive Ingredients
povidone, sodium starch glycolate, starch stearic acid.
How Supplied
Product: 50090-5148
NDC: 50090-5148-2 100 TABLET in a BOTTLE
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