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| Product NDC Code | 37000-024 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Metamucil therapy for regularity |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | POWDER | ||||||
| RxCUI drug identifier | 824586, 880853 |
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| Application Number | M007 | ||||||
| Labeler Name | The Procter & Gamble Manufacturing Company | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Metamucil Therapy for regularity
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, contact a doctor or a Poison Control Center right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each PACKET) Psyllium husk approximately 3.4 g
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 Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. For a lighter flavor experience and thinner drink, use more water. Adults 12 yrs. & older 1 packet in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. 6 – 11 yrs. 1/2 packet in 8 oz of liquid, up to 3 times daily Under 6 yrs. Consult a doctor As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating. New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary.
| Adults 12 yrs. & older | |
| 6 – 11 yrs. | 1/2 packet in 8 oz of liquid, up to 3 times daily |
| Under 6 yrs. | Consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aspartame, citric acid, FD&C Yellow No. 6, maltodextrin, natural and artificial orange flavor
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 occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.
Purpose
Information about the drug product’s indications for use.Active ingredient (in each PACKET) Purpose Fiber laxative
Spl product data elements
Usually a list of ingredients in a drug product.Metamucil Therapy for regularity Psyllium Husk CITRIC ACID MONOHYDRATE ASPARTAME FD&C YELLOW NO. 6 MALTODEXTRIN PSYLLIUM HUSK PSYLLIUM HUSK
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.PRINCIPAL DISPLAY PANEL MetaMUCIL PSYLLIUM FIBER SUPPLEMENT THERAPY FOR REGULARITY on-the-go! 30 packets 4-in-1 FIBER HELPS SUPPORT: Appetite Control* Heart Health by Lowering Cholesterol† Healthy Blood Sugar Levels* Digestive Health * SUGAR-FREE not a low calorie food †See back for information about soluble fiber and heart disease ORANGE fiber powder / naturally and artificially flavored 30-0.21 OZ (5.8 g) POWDER PACKETS/NET WT 6.2 OZ (176 g) *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. 024
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.Drug Facts
• Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.
ALLERGY ALLERT: This product may cause allergic reactions in people sensitive to inhaled or ingested psyllium.
INDIVIDUAL PACKETS SEALED FOR YOUR PROTECTION
DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202
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 you have • abdominal pain, nausea or vomiting • a sudden change in bowel habits persisting for 2 weeks
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-983-4237
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 • constipation lasts more than 7 days • rectal bleeding occurs • you fail to have a bowel movement These may be signs of a serious condition.
Storage and handling
Information about safe storage and handling of the drug product.Other information each packet contains: potassium 30 mg; sodium 5 mg PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per packet Store below 86º F (30º C)
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