Active Ingredient(S)
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg
Menstrual Complete Tablet, Film Coated
FDA Label NDC 69168-470
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Menstrual Complete (NDC 69168-470). 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 ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, 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
Use(S)
for the temporary relief of these symptoms associated
with menstrual periods:
■ water-weight gain ■ backache ■ muscle aches
■ cramps ■ fatigue ■ headache ■ bloating
Warnings
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ 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.
■ if you have ever had an allergic reaction to this product or
any of its ingredients
Ask A Doctor Before Use If
you have
■ difficulty in urination due to enlargement of the prostate
gland ■ liver disease ■ glaucoma
■ 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
■ drowsiness may occur
■ alcohol, sedatives, and tranquilizers may increase
drowsiness ■ avoid alcoholic beverages
■ excitability may occur, especially in children
■ use caution 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 heart rate. 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 occur
■ redness or swelling is present
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
If Pregnant Or Breastfeeding,
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.
Prompt medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.
Directions
■ do not take more than directed
■ adults and children 12 years and over:
■ take 2 caplets with water
■ repeat every 6 hours, as needed
■ do not exceed 6 caplets per day
■ children under 12 years: ask a doctor
Other Information
■ store at 25°C (77°F); excursions permitted between
15°-30°C (59°-86°F) ■ use by expiration date on package
Inactive Ingredients
corn starch, croscarmellose sodium, crospovidone,
hypromellose, magnesium stearate, microcrystalline
cellulose, polydextrose, polyethylene glycol, povidone, silicon
dioxide, stearic acid, titanium dioxide, triacetin
Questions/Comments
1-888-952-0050
Principal Display Panel
Menstrual Complete
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