Pre Menstrual relief

Amerisource Bergen
P and L Development of New York Corporation

DRUG FACTS

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredients (in each caplet)
  • Purpose
• Pre Menstrual relief Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Pre Menstrual relief Other information
• Inactive Ingredients
• Questions or Comments?
• Package label

FULL PRESCRIBING INFORMATION

Active Ingredients (in each caplet)

Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine Maleate 15 mg

Purpose

Pain Reliever
Diuretic
Antihistimine/Diuretic

Pre Menstrual relief Uses

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

• cramps
• bloating
• breast tenderness

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday while using this product

Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. 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 children even if you do not notice any signs or symptoms.

Do not exceed recommended dose.

Do not use

• with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

When using this product

• you may get drowsy
• excitability may occur, especially in children
• alcohol, sedatives and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain persists for more than 10 days.

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children.

Directions

• do not take more than the recommended dose (See overdose warning)
• adults and children 12 years of age and older: take 2 caplets with water
• repeat every 6 hours, as needed
• do not exceed 8 caplets per day
• children under 12 years of age: consult a doctor

Pre Menstrual relief Other information

• store at 15^o-30^o C (59^o-86^o F)
• *This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Midol®

Inactive Ingredients

croscarmellose sodium, hypromellose, magnesium silicate, magnesium stearate, microcrystalline celulose, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin.

Questions or Comments?

Call toll free 1-877-753-3935

Package label

*Compare to Midol® Maximum strength Premenstrual Syndrome Formula active ingredients

See New Warnings Information

Maximum strength

Pre- Menstrual Relief

acetaminophen, pamabrom, pyrilamine maleate

pain reliever/ Diuretic/ Antihistamine

Cramps, Bloating, Breast Tenderness

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION