Otc - Active Ingredient
Active ingredient (in each caplet)
Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg
The following Structured Product Label (SPL) was submitted to the FDA by Hart Health for the product Fem-prin (NDC 50332-0145). 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 - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each caplet)
Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg
Purpose
Pain reliever/fever reducer
Diuretic
Antihistamine
Uses
for the temporary relief of minor aches, pain, and water weight gain due to mentrual cycle
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ 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 reddening
■ blisters
■ rash
Do not use
■ with any other drug containing acetaminophen (prescription or nonprescription).
Ask a doctor before use if you have
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
■ liver disease
■ glaucoma
Ask a doctor or pharmacist before use if
■ you do not know if other drugs you are taking contain acetaminophen
■ you are taking sedatives or tranquilizers
■ you are taking the blood thinning drug warfarin
When using this product
■ drowsiness may occur
■ avoid alcoholic beverages
■ alcohol, sedatives and tranquilizers may increase drowsiness
■ use caution when driving a motor vehicle or operating machinery
■ excitability may occur, especially in children
Stop use and ask a doctor if
■ an allergic reaction occurs, seek medical help right away
■ fever worsens or lasts more than 3 days
■ pain worsens or lasts more than 10 days
■ new symptoms occur
■ redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Directions
Do not take more than directed
Adults and children 12 years of age and over
■ take 2 caplets every 6 hours while symptoms persist
■ do not take more than 6 caplets in 24 hours unless directed by a doctor
Children under 12 years: ask a doctor
Other information
■ caplets enclosed in a sealed packet
■ do not use if packet is torn, cut or open
■ store at 59° to 86°F (15°-30°C)
■ avoid excessive heat and humidity
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide
* Please review the disclaimer below.