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| Product NDC Code | 0904-5675 | ||||
|---|---|---|---|---|---|
| Drug Name | 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 | M007 | ||||
| Labeler Name | Major Pharmaceuticals | ||||
| 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 19g adult dose/ rounded tablespoon) Methylcellulose 2g (a non-allergenic fiber)
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 above 12 years of age and over One rounded tablespoon. (19 g) in 8 ounces of water fluid up to 3 times daily at the first sign of constipation or irregularity children 6 - 12 years of age Children under 6 years of age half the adult dose in 8 ounces of water once daily. ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, FD&C yellow 6 aluminum lake, maltodextrin, flavor (natural and artificial), potassium citrate, , silica, sucrose,
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) • helps to restore and maintain regularity • for treating bowel disorders when recommended by a doctor • generally provide effect 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.FIBER THERAPY methylcellulose METHYLCELLULOSE (4000 MPA.S) METHYLCELLULOSE (4000 MPA.S) CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 POTASSIUM CITRATE RIBOFLAVIN SUCROSE SILICON DIOXIDE SORBITOL TALC
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 NDC 0904-5675-16 FIBER THERAPY Methylcellulose Easy to Mix No Gritty Texture 100% Soluble Fiber for Controlled Regularity ORANGE FLAVOR NET WT 16 OZ (454 GRAMS) Fiber Therapy
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 adult dose contains approximately • 3mg of sodium • 105mg potassium • contributes 60 calories from sucrose and sorbitol • store at room temperature • protect contents from humidity • keep tightly closed Tamper Evident: Do not use if printed seal under cap is torn or missing
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 • abdominal pain, nausea or vomiting • a sudden change in bowel habits that persists over a period of 2 weeks • sensitivity to any of the ingredients
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? call toll-free 1-800-616-2471 *This product is not manufactured or distributed by GlaxoSmithKline the distributor of CITRUCEL® Distributed by: MAJOR ® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152, USA DIRECTIONS FOR USE 1. Fill glass with at least 8 ounces of cold water. 2. Add the adult or child dose listed in the directions. 3. Stir briskly until dissolved and drink promptly. Drinking an additional glass of water is helpful. TAMPER EVIDENT PACKAGE Do not use if printed seal under cap is torn or missing. Image of pouring water into glass Image of stirring water after adding Citrucel
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 • you have rectal bleeding • you fail to have a bowl movement after use. • These could be signs of a serious condition.
Boxed warning
Information about contraindications or serious warnings, particularly those that may lead to death or serious injury.TAMPER EVIDENT PACKAGE Do not use if printed seal under cap is torn or missing.
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 • abdominal pain, nausea or vomiting • a sudden change in bowel habits that persists over a period of 2 weeks • sensitivity to any of the ingredients Stop use and ask a doctor if • you have rectal bleeding • you fail to have a bowl movement after use. • 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. When using this product • do not exceed recommended maximum daily dose unless directed by a doctor • do not use laxative products for a period longer than one week unless directed by a doctor
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