Otc - Active Ingredient
ACTIVE INGREDIENT IN EACH TABLET-
Acetaminophen 500 mg
Non-aspirin
FDA Label NDC 67060-210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced First Aid, Inc. for the product Non-aspirin (NDC 67060-210). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
pain reliever/fever reducer
Indications & Usage
Uses: temporarily relieves minor aches and pains associated with: • headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache
Warnings
Warnings:
Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: • you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product
Do not use: • with any other product containing acetaminophen • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor
When using this product do not exceed recommended dose.
Stop use and ask a doctor if: • symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding baby, ask a health professional before use.
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. Prompt 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 of age and older: Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or asdirected by a doctor.
Children under 12 years: Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.
Inactive Ingredient
Inactive Ingredients: corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid
Package Label.Principal Display Panel
Advanced Non Aspirin (Nonaspirinbox)
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