pamabrom

FDA Drug Profile — Midol Bloat Relief

Drug Details

Generic Name
pamabrom
Brand Names
Midol Bloat Relief
Application Number
M027
Sponsor
Bayer HealthCare LLC.
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
PAMABROM

Indications and Usage

Uses for the temporary relief of these symptoms associated with menstrual periods: • cramps • headache • bloating • backache • water-weight gain • muscular aches • irritability

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 caplets in 24 hours, which is the maximum daily amount • 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 If a skin reaction occurs, stop use and seek medical help right away. Do not use with any other drug 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 • a breathing problem such as emphysema or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • you may get drowsy, avoid alcoholic beverages • alcohol, sedatives and tranquilizers may increase drowsiness • use caution when driving or operating machinery • excitability may occur, especially in children Stop use and ask a doctor if • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days • new symptoms occur • redness or swelling is present If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.