Menstrual Complete Tablet
FDA Label NDC 70692-131

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Menstrual Complete (NDC 70692-131). 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 drug facts, active ingredients (in each gelcap), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients (In Each Gelcap)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purposes

Pain reliever
Diuretic
Antihistamine

Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 6 gelcaps 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: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: • hives • blisters • rash • skin reddening • 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
• 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.

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

If pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
Overdose warning: 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 children even if you do not notice any signs or symptoms.

Directions

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

Other Information

Store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive Ingredients

croscarmellose sodium, D&C red#33 aluminium lake, edible black printing ink, ethyl cellulose, FD&C blue #1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, pregelatinized potato starch, PVPK-30, sorbitol sorbitan solution, talc, titanium dioxide, triacetin

Questions Or Comments?

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Packaging

Menstrualcomplete (7069213124 01)

Menstrualcomplete (7069213124 01)

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