Otc - Active Ingredient
Acetaminophen
Tylo
FDA Label NDC 49638-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by America Medic for the product Tylo (NDC 49638-002). 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 - keep out of reach of children, otc - purpose, dosage & administration, inactive ingredient, indications & usage, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help right away and contact a poison control center right away.
Otc - Purpose
Oral Analgesic
Dosage & Administration
Adults and children 12 years and over: Take 2 tablets at bedtime(Do not take more than 2 tablets in a 24 hour time)
Inactive Ingredient
Povidonepregelatinized starchstearic acid
Indications & Usage
Oral analgesic.
Warnings
Do not use this product if you have had an allergic to Acetaminophen or any of the inactive ingredients. Ask a doctor before taking this product if you have Liver disease or are taking blood thinning medication. Do not take more than directed.If pregnant or breast feeding contact a doctor before using this product. Stop use and consult a doctor if: Pain gets worse or last more than 10 days: If fever gets worse or last more than 3 days: new symptoms appear: redness or swelling appear.
Package Label.Principal Display Panel
image of carton
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