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| Product NDC Code | 52389-406 | ||||
|---|---|---|---|---|---|
| Drug Name | Diurex water pills xpl |
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| Type | Brand | ||||
| Pharm Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, FILM COATED | ||||
| Application Number | M027 | ||||
| Labeler Name | Alva-Amco Pharmacal Companies, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each pill) Caffeine Anhydrous, 100 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Read all package directions and warnings before use. Use only as directed. Adults: One (1) pill (100mg) or two (2) pills (200 mg maximum strength) every 3 to 4 hours while symptoms persist, not to exceed 8 pills in a 24 hour period. Start taking 5 or 6 days before onset of period and continue use until desired relief is obtained or end of period. Drink 6 to 8 glasses of water daily. Recommended for use by normally healthy adults only.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acacia, calcium carbonate, croscarmellose sodium, D&C Yellow No. 10 Lake, ethyl vanillin, FD&C Blue No. 1 Lake, FD&C Blue No. 2 Lake, hypromellose, lactose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate, stearic acid and titanium dioxide.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For relief of symptoms associated with the premenstrual and menstrual periods including: temporary water retention bloat swelling full feeling fatigue
Purpose
Information about the drug product’s indications for use.Purpose Diuretic
Spl product data elements
Usually a list of ingredients in a drug product.Diurex Water Pills XPL Caffeine CALCIUM CARBONATE CROSCARMELLOSE SODIUM ETHYL VANILLIN D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 ACACIA HYPROMELLOSES TALC MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POLYSORBATE 80 STEARIC ACID TITANIUM DIOXIDE LACTOSE MONOHYDRATE ANHYDROUS LACTOSE CAFFEINE CAFFEINE light green ALVA
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Diurex XPL PDP
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DiurexXPL Spanish Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if taking any other medications under 18 years of age. Do not give to children under 12 years of age.
Diurex Water Pills XPL: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Other information Calcium content: 30 mg/pill **Contents sealed: Each DIUREX light green colored, round shaped pill bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a foil backing. Do not use if seal appears broken or if product contents do not match product description. You may report serious side effects to the phone number provided under Questions? below.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-792-2582
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if symptoms last for more than ten consecutive days.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause: nervousness irritability sleeplessness occasional rapid heart beat. The recommended dose of this product contains about as much caffeine as one to two cups of coffee.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API