Otc - Active Ingredient
Active ingredient (in each tablet) Acetaminophen 500 mg |
Acetaminophen
FDA Label NDC 49483-252
14 label sections · Submitted to the FDA by Time Cap Laboratories, Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc for the product Acetaminophen (NDC 49483-252). 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 - 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.
Label Section Quick Index
Otc - Purpose
Purpose Pain reliever/fever reducer |
Indications & Usage
Uses
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Warnings
Warnings
Liver warning:
This product contains Acetaminophen. Severe liver damage may occur if you have:
more than 8 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include *skin redding *blisters *rash.
If a skin reaction occurs, stop use and seek medical help right away.
Otc - Do Not Use
Do not use
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Otc - Ask Doctor
Ask a doctor before use if you have
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Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
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Otc - Stop Use
Stop use and ask a doctor if
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. |
Overdosage
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. |
Dosage & Administration
Directions
adults and children 12 years and over
children under 12 years
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Storage And Handling
Other information
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Inactive Ingredient
Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
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* Please review the disclaimer below.
