PRE MENSTRUAL RELIEF MAXIMUM STRENGTH
(acetaminophen, pamabrom, pyrilamine maleate)
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph not final|
Active Ingredients (in each caplet)
Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine Maleate 15 mg
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
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
- 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.
- 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 15o-30o C (59o-86o F)
- *This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Midol®
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.
*Compare to Midol® Maximum strength Premenstrual Syndrome Formula active ingredients
See New Warnings Information
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
Pre menstrual relief caplets
|PRE MENSTRUAL RELIEF
acetaminophen, pamabrom, pyrilamine maleate tablet
|Labeler - Amerisource Bergen (007914906)|
|Registrant - P and L Development of New York Corporation (800014821)|