- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
- Supplemental Patient Material
- Boxed Warning
- Patient Package Insert
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active Ingredients (in each caplet)
- Other information
- Inactive Ingredients
- Questions or comments?
- Package labeling
FULL PRESCRIBING INFORMATION
Active Ingredients (in each caplet)
Pyrilamine Maleate 15mg
for the temporary relief of these symptoms associated with menstrual periods:
- breast tenderness
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
Do not use
- with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, as a doctor or pharmacist.
As a doctor before use if you have
- liver disease
- 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 gets worse or lasts more than 10 days
Pregnant or breast-feeding
ask a health professional before use
Keep out of reach of children.
- 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
store at 15-30degreesC (59-86degreesF)
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 1-800-200-6313
SEE NEW WARNINGS INFORMATION NDC 37205-339-62
Leader Maximum Strength Premenstrual Relief
Pamabrom, Pyrilamine Maleate
Relieves: Cramps, Bloating, Tenderness
Distributed By Cardinal Health
Dublin, Ohio 43017
All Leader brand products are 100% satisfaction guaranteed or return to place of purchase for full refund.
ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE CAPSULE