Drug Facts
Active Ingredient (in each tablet)
Acetaminophen 500 mg
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Acetaminophen (NDC 50090-5313). 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 drug facts, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient (in each tablet)
Acetaminophen 500 mg
Purpose
Pain reliever/ Fever reducer
Temporarily reduces fever and relieves minor aches and pains due to:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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.
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.
Keep out of reach of children.
Overdose warning: 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 for children even if you do not notice any signs or symptoms.
adults and children 12 years and over:
• take 2 tablets every 6 hours while symptoms last
• do not take more than 6 tablets in 24 hours, unless directed by a doctor
• do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor
store at room temperature
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Call (800) 616-2471
SAVE CARTON FOR COMPLETE DRUG FACTS
Do not use if carton is open or if imprinted safety seal under cap is broken or missing.
Distributed By:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®
Product: 50090-5313
NDC: 50090-5313-1 30 TABLET in a BOTTLE
NDC: 50090-5313-2 100 TABLET in a BOTTLE
NDC: 50090-5313-3 50 TABLET in a BOTTLE
NDC: 50090-5313-4 24 TABLET in a BOTTLE
NDC: 50090-5313-5 20 TABLET in a BOTTLE
* Please review the disclaimer below.