FDA Label for Fem-prin
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING: TAKING MORE THAN THE RECOMMENDED DOSE (OVERDOSE) MAY CAUSE LIVER DAMAGE. QUICK MEDICAL ATTENTION IS CRITICAL FOR ADULTS AS WELL AS FOR CHILDREN EVEN IF YOU DO NOTICE ANY SIGNS OR SYMPTOMS. IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. 1-800-222-1222
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Fem-prin Product Label
The following document was submitted to the FDA by the labeler of this product Hart Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each caplet)
Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Diuretic
Antihistamine
Indications & Usage
Uses
for the temporary relief of minor aches, pain, and water weight gain due to mentrual cycle
Warnings
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
Otc - Do Not Use
Do not use
■ with any other drug containing acetaminophen (prescription or nonprescription).
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
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
Otc - When Using
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
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning: Taking More Than The Recommended Dose (Overdose) May Cause Liver Damage. Quick Medical Attention Is Critical For Adults As Well As For Children Even If You Do Notice Any Signs Or Symptoms. In Case Of Overdose, Get Medical Help Or Contact A Poison Control Center Right Away. 1-800-222-1222
Dosage & Administration
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 Safety Information
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 Ingredient
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
Package Label.Principal Display Panel
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