Active Ingredient
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg
The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Menstrual Complete (NDC 72090-026). 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, purpose, uses:, warnings:, ask doctor:, ask doctor/pharmacist:, when using this product, pregnancy, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg
Pain reliever,Diuretic, Antihistamine
for the temporary relief of these symptoms associated with menstrual periods:
cramps
bloating
water-weight gain
headache
backache
muscle aches
fatigue
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert:
Acetaminophen may cause sever skin or sever allergy reactions. Symptoms may include:
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
you may get drowsy
avoid alcoholic drinks
excitability may occur, especially in children
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
limit the use of caffeine-containing medications, foods, or beverages 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.
If pregnant or breast-feeding, ask a health professional before use.
Overdose Warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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
store at room temperature
carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin
Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com
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
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