Drugplain

Midol Complete Caffeine Free 500 mg/1

ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE · TABLET · Bayer HealthCare LLC.

No Recall HistoryCurrently in Shortage
Plain English

Midol Complete Caffeine Free is an over-the-counter tablet containing acetaminophen and pyrilamine maleate that is used to relieve menstrual pain and other symptoms associated with periods. It combines a pain reliever with an antihistamine to help reduce cramping and discomfort.

Key Facts

Brand Name
Midol Complete Caffeine Free
Generic Name
ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE
NDC Code (Product)
0280-0078
Manufacturer
Bayer HealthCare LLC.
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M027
Marketing Start
01/29/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

blister1 reports
cheilitis1 reports
chills1 reports
cough1 reports
decreased appetite1 reports
dehydration1 reports
diarrhoea1 reports
dizziness1 reports
fatigue1 reports
feeding disorder1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions do not take more than the recommended dose adults and children 12 years and older: take 2 caplets with water repeat every 6 hours, as needed do not exceed 6 caplets per day children under 12 years: consult a doctor

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy Alert acetamonophen may cause severe skin or severe allergic reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock If a skin or general allergic 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease glaucoma difficulty in urination due to 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 the blood thinning drug warfarin taking sedatives or tranquilizers When using this product you may get drowsy avoid alcoholic drinks excitabi

Frequently Asked Questions

What is Midol Complete Caffeine Free used for?

Midol Complete Caffeine Free is an over-the-counter tablet containing acetaminophen and pyrilamine maleate that is used to relieve menstrual pain and other symptoms associated with periods. It combines a pain reliever with an antihistamine to help reduce cramping and discomfort.

Is Midol Complete Caffeine Free a controlled substance?

Midol Complete Caffeine Free is not classified as a controlled substance by the DEA.

What is the generic name for Midol Complete Caffeine Free?

The generic name for Midol Complete Caffeine Free is ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE. There are 9 other brand versions of ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE.

What is the NDC code for Midol Complete Caffeine Free 500 mg/1?

The NDC (National Drug Code) for Midol Complete Caffeine Free 500 mg/1 is 0280-0078, listed by Bayer HealthCare LLC..