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| Product NDC Code | 37808-716 | ||||
|---|---|---|---|---|---|
| Drug Name | Heb fiber therapy |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | POWDER, FOR SOLUTION | ||||
| RxCUI drug identifier | 1868843 | ||||
| Application Number | part334 | ||||
| Labeler Name | HEB | ||||
| 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 rounded tablespoon) (in each rounded tablespoon) Methylcellulose (a non-allergenic fiber) 2g
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 • MIX THIS PRODUCT (CHILD OR ADULT DOSE) WITH AT LEAST 8 OUNCES (A FULL GLASS) OF WATER OR OTHER FLUID. TAKING THIS PRODUCT WITHOUT ENOUGH LIQUID MAY CAUSE CHOKING. SEE CHOKING WARNING • use product at the first sign of constipation or irregularity • put one dose in a full glass of cold water • stir briskly and drink promptly • drinking another glass of water is helpful Age Dose adults & children 12 years of age and over start with 1 heaping tablespoon . Increase as needed, 1 heaping tablespoon at a time, up to 3 times per day. children 6 - 11 years of age start with 2.5 level teaspoons . Increase as needed, 2.5 level teaspoons at a time, up to 3 times per day. children under 6 years of age consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, FD&C yellow #6 lake, flavor, maltodextrin, potassium citrate, silica, sucralose, tricalcium phosphate, Questions or comments? 1-866-467-2748
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 ▪ relieves constipation (irregularity) ▪ generally produces a bowel movement in 12-72 hours
Purpose
Information about the drug product’s indications for use.Purpose Bulk-forming fiber laxative
Spl product data elements
Usually a list of ingredients in a drug product.HEB Fiber Therapy methylcellulose METHYLCELLULOSE (4000 MPA.S) METHYLCELLULOSE (4000 MPA.S) ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 MALTODEXTRIN POTASSIUM CITRATE SILICON DIOXIDE SUCRALOSE TRICALCIUM PHOSPHATE
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 HEB ® Compare to the Active Ingredient in Citrucel ® Powder* NDC 37808-716-16 Fiber METHYLCELLULOSE FIBER THERAPY • Gentle and clinically proven effective** • Gives you additional fiber to help balance your diet • Won’t cause excess gas** SUGAR FREE ORANGE FLAVOR Naturally & Artificially Flavored NET WT 16.9 OZ (1.06 LB) (479g) Directions for use: 1. Fill glass with at least 8 ounces of cold water. 2. Add the recommended dose listed in directions. 3. Stir briskly until dissolved completely and drink promptly .Drinking an additional glass of water is helpful. TAMPER EVIDENT: DO NOT USE PRINTED INNER SEAL IS BROKEN OR MISSING GLUTEN FREE *This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Citrucel ® . MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204 100% GUARANTEE promise If you aren’t completely pleased with this product, we’ll be happy to replace it or refund your money. You have our word on it. HEB FIBER THEREPY METHYCELLULOSE
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.Other information • each heaping tablespoon contains: calcium 85mg and potassium 125mg • each heaping tablespoon contributes 24 calories from maltodextrin • store below at room temperature • protect contents from humidity • keep tightly closed
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 before use if you have ▪ a sudden change in bowel habits that persists for two weeks ▪ abdominal pain, nausea or vomiting
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 at 1-800-222-1222.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-467-2748
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 ▪ you have rectal bleeding These could be signs of a serious condition.
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 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. Ask a doctor before use if you have ▪ a sudden change in bowel habits that persists for two weeks ▪ abdominal pain, nausea or vomiting Stop use and ask a doctor if ▪ constipation lasts more than 7 days ▪ you have rectal bleeding These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
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