Midol Complete (caffeine 60 mg pyrilamine maleate 15 mg acetaminophen 500 mg) Dailymed

Drug Facts

Otc - Active Ingredient Section

Active ingredients (in each gelcap) Purpose

Acetaminophen 500 mg..............................………………….Pain reliever

Caffeine 60 mg……….…………………………………….……..….Diuretic

Pyrilamine maleate 15 mg……………………………………Antihistamine

Purpose

Indications & Usage Section

Uses for the temporary relief of these symptoms associated with menstrual periods:

• cramps
• bloating
• water-weight gain
• headache
• backache
• muscle ache
• fatigue

Warnings Section

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:

· skin reddening · bulers · rash

· hives · facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Otc - Do Not Use Section

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

Otc - Ask Doctor Section

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

Otc - Ask Doctor/pharmacist Section

Ask a doctor or pharmacist before use if you are · taking the blood thinning drug warfarin · taking sedatives or tranquilizers

Otc - When Using Section

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.

Otc - Stop Use Section

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

Otc - Pregnancy Or Breast Feeding Section

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

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration Section

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 Safety Information

Other information

· store at room temperature

· avoid excessive heat 104°F (40°C)

Inactive Ingredient Section

Inactive ingredients black iron oxide, carnauba wax, croscarmellose sodium, D&C red #33 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, simethicone, stearic acid, titanium dioxide, triacetin

Otc - Questions Section

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

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