FDA Label for Menstrual Pain Relief Complete

Other

Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

Active Ingredient (In Each Liquid-Filled Capsule)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purpose

Pain reliever
Diuretic
Antihistamine

Uses

for the temporary relief of these symptoms associated with menstrual periods:

• cramps
• bloating
• water
• weight gain
• headache
• backache
• muscle aches
• fatigue

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
• hives
• facial swelling
• asthma (wheezing)
• shock

If a skin reaction occurs, stop use and seek medical help right away.

Otc - Do Not Use

Do not use

• if you have ever had an allergic reaction to this product or any of its ingredients
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Otc - Ask Doctor

Ask a doctor before use if you have

• difficulty in urination due to enlargement of the prostate gland
• liver disease _ glaucoma
• a breathing problem such as emphysema or chronic

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if youare

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

Otc - When Using

When using this product

• avoid alcoholic beverages
• excitability may occur, especially in children
• be careful when driving a motor vehicle or operating machiner
• alcohol, sedatives, and tranquilizers may increase drowsiness
• you may get drowsy
• limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Otc - Stop Use

Stop use and ask a doctor if

• new symptoms occur _ redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days

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. 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.

Directions

adults and children 12 years and over:

• do not take more than the recommended dose
• adults and children 12 years and over: take 2 caplets with water
• repeat every 6 hours, as needed
• do not exceed 6 caplets per day
• children under 12 years: ask a doctor

Other Information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

aerosil, calcium phosphate, colloidal silicon dioxide, cross carmellose sodium, FD&C yellow #6, hypromellose, isopropyl alcohol, magnesium stearate, methlyene chloride, microcrystalline cellulose, pregelatinized starch, polyethylene glycols, poly vinyl pyrrolidone, povidone, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

Menstrual Pain Relief Complete

Acetaminophen/Caffeine/Pyrilamine maleate

Pain reliever/Diuretic/Antihistamine

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