Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 500mg
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Pain Reliever (NDC 66715-9637). 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, liver warning, allergy alert, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each tablet)
Acetaminophen 500mg
Purpose
Pain reliever/fever reducer
Uses
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
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 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
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
Other information
Inactive ingredients
corn starch, hypromellose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?
call toll-free 1-877-507-6516 (M-F 8 AM-4:30PM CST)
Extra Strength
Pain Reliever
Acetaminophen, 500 mg
Pain Reliever/Fever Reducer
10
Tablets
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