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FEM-PRIN


OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg


OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Diuretic

Antihistamine


INDICATIONS & USAGE SECTION

Uses

for the temporary relief of minor aches, pain, and water weight gain due to mentrual cycle


WARNINGS SECTION

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 SECTION

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription).


OTC - ASK DOCTOR SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

If pregnant or breast-feeding, ask a health professional before use.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

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