Otc - Active Ingredient
Aspirin
Aspirin
FDA Label NDC 49638-001
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 Aspirin (NDC 49638-001). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, 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 - Purpose
Internal Analgesic.
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.
Indications & Usage
Oral Analgesic. Aspirin is not appropriate for everyone, so be sure to talk to a doctor before starting an Aspirin regimen.
Warnings
Do not use this product if you are allergic to Aspirin or any other pain/fever product.If pregnant or breastfeeding contact a doctor before using.Contact a doctor or pharmacist if you are taking a prescription drug for-Gout, Diabetes or Arthritis.Contact a doctor right away if: An allergic reaction occurs.
Dosage & Administration
Drink a full glass of water with each dose.Adults and children 12 years of age and up:Take 4-8 tablets every 4 hours not to exceed 48 tablets in 24hours unless indicated by a doctor.. Children under 12 years of age : Consult a Doctor.
Inactive Ingredient
Yellow # 10
Yellow # 6
Methacrylic Acid Copolymer
Microcrystalline Cellose
Stearic Acid
Titanium Dioxide
Triethyl Citrate
Package Label.Principal Display Panel
Image Of Carton (Aspirin 81 Box)
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