Label: PRE MENSTRUAL RELIEF MAXIMUM STRENGTH- acetaminophen, pamabrom and pyrilamine maleate tablet
- NDC Code(s): 46122-021-62
- Packager: Amerisource Bergen
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredients (in each caplet)
Acetaminophen 500 mgClose
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
- Other information
- 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®
- 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.Close
- Questions or Comments?
Call toll free 1-877-753-3935Close
- Package label
*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
- INGREDIENTS AND APPEARANCE
PRE MENSTRUAL RELIEF MAXIMUM STRENGTH
acetaminophen, pamabrom, pyrilamine maleate tablet
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46122-021 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg PAMABROM (BROMOTHEOPHYLLINE) PAMABROM 25 mg PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 15 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM SILICATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MINERAL OIL POVIDONE K15 STARCH, CORN SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN Product Characteristics Color WHITE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code CPC2826 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-021-62 2 in 1 CARTON 1 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 01/07/2011 Labeler - Amerisource Bergen (007914906) Registrant - P and L Development of New York Corporation (800014821)