DOSAGE & ADMINISTRATION SECTION.
Directions do not take more than the recommended dose. adults and children 12 years and older: take gelcaps with water repeat every hours, as needed do not exceed gelcaps per day. children under 12 years: consult doctor.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients black iron oxide, carnauba wax, croscarmellose sodium, D&C red 33 aluminum lake, edetate disodium, FD&C blue aluminum lake, gelatin, glycerin, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, simethicone, stearic acid, titanium dioxide, triacetin.
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INDICATIONS & USAGE SECTION.
Uses for the temporary relief of these symptoms associated with menstrual periods: crampsbloatingwater-weight gainheadachebackachemuscle achefatigue. cramps. bloating. water-weight gain. headache. backache. muscle ache. fatigue.
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OTHER SAFETY INFORMATION.
Other information. store at room temperature. avoid excessive heat 104F (40C).
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredients (in each gelcap) PurposeAcetaminophen 500 mg....................................................Pain relieverCaffeine 60 mg.................................................................DiureticPyrilamine maleate 15 mg..........................................Antihistamine.
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OTC - ASK DOCTOR SECTION.
Ask 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.
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OTC - ASK DOCTOR/PHARMACIST SECTION.
Ask doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers.
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OTC - DO NOT USE SECTION.
Do not use. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. if you have ever had an allergic reaction to this product or any of its ingredients.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children. In case of overdose, get medical help or contact 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.
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OTC - PREGNANCY OR BREAST FEEDING SECTION.
If pregnant or breast-feeding, ask health professional before use.
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OTC - QUESTIONS SECTION.
Questions or comments 1-800-331-4536 (Mon-Fri 9AM 5PM EST).
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OTC - STOP USE SECTION.
Stop use and ask 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 days.
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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 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 cup of coffee.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
midolcompletegelcaps.
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SPL UNCLASSIFIED SECTION.
Drug Facts.
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WARNINGS SECTION.
WarningsLiver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than gelcaps in 24 hours, which is the maximum daily amountfor this product. with other drugs containing acetaminophen. or more alcoholic drinks every day while using this productAllergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:. skin reddening blisters rash. hives facial swelling asthma (wheezing) shockIf skin or general allergic reaction occurs, stop use and seek medical help right away.
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