Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg
Menstrual Relief Tablet, Film Coated
FDA Label NDC 11673-390
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Menstrual Relief (NDC 11673-390). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Diuretic
Antihistamine
Uses
- for the temporary relief of these symptoms associated with menstrual periods:
- cramps
- bloating
- water-weight gain
- headache
- backache
- breast tenderness
- fatigue
- muscle aches
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinnks every day while using this product
Do Not Use
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, aska doctor or pharmacist.
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
- alcohol, sedatives and tranquilizers may increase
- avoid alcoholic drinks
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
- limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop Use And Ask A Doctor If
- new symptoms appear
- redness or swelling is present
- pain gets worse or lasts more than 10 days
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: Taking more than the reocmmended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than the recommended dose
(see overdose warning) - adults and children 12 years and older:
- take 2 caplets with water
- repeat every 6 hours, as needed
- do not exceed 8 caplets in 24 hours
- children under 12 years: ask a doctor
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
cellulose, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin
Questions?
Call 1-800-910-6874
Principal Display Panel
NDC 11673-390-10
Compare to active ingredients in Midol® Menstrual Complete*
menstrual relief
maximum strength caplets
acetaminophen, 500 mg
caffeine, 60 mg
pyrilamine maleate, 15 mg
for relief of cramps, bloating, fatigue, headache and backache
up & up®
40 CAPLETS
*This product is not manufactured or distributed by Bayer HealthCare, LLC, owner of the registered trademark Midol® Complete.
50844 REV0913C39010
094 01 0304 ID201416
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
* Please review the disclaimer below.
