Otc - Active Ingredient
Acetaminophen 325mg
Pamabrom 25mg
Femadrine
FDA Label NDC 51532-0700
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Afassco Inc. for the product Femadrine (NDC 51532-0700). 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 - ask doctor/pharmacist, otc - keep out of reach of children, otc - pregnancy or breast feeding, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain reliever, Diuretic
Indications & Usage
Uses: For the relief of:
• cramps • bloating • water-weight gain
• headaches • backaches • muscular aches and pains
Warnings
Warnings:
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours
• with any other drugs containing acetaminophen (prescription or non-prescription).
• 3 or more alcoholic drinks a while using this product.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Overdosage
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: Do not use more than directed.
Adults and children: (12 years and older) Take 2 tablets with water. Repeat every 4 hours, as needed, not to exceed 8 tablets in any 24 hour period.
Children under 12 years of age: Consult a doctor.
Inactive Ingredient
SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION
Package Label.Principal Display Panel
Afasscofemadrine12-16 (Afassco Femadrine)
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