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| Product NDC Code | 0135-0199 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Citrucel |
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| Type | Brand | ||||||||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||||||||
| Dosage Form | TABLET | ||||||||||||||
| RxCUI drug identifier | 198750, 352178 |
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| Application Number | M007 | ||||||||||||||
| Labeler Name | Haleon US Holdings LLC | ||||||||||||||
| 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 caplet) Methylcellulose (a non-allergenic fiber) 500mg
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 Take 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. Age Dose Maximum Dose adults & children 12 years of age and over start with 2 caplets. Increase as needed up to 6 times per day. do not exceed 12 caplets per day children 6 - 11 years of age start with 1 caplet. Increase as needed up to 6 times per day. do not exceed 6 caplets per day children under 6 years of age consult a physician consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients crospovidone, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate
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 occasional 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.CITRUCEL methylcellulose CROSPOVIDONE, UNSPECIFIED ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C YELLOW NO. 6 MAGNESIUM STEARATE MALTODEXTRIN POVIDONE, UNSPECIFIED SODIUM LAURYL SULFATE METHYLCELLULOSE (4000 MPA.S) METHYLCELLULOSE (4000 MPA.S) Caplet CIT
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 0135-0199-01 CITRUCEL METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY Easy Flip Top Cap • Gentle and clinically proven effective* • Gives you additional fiber to help relieve occasional constipation • Fiber for regularity that won’t cause excess gas** 180 Fiber caplets 105120XC 105120XC_Citrucel Caplets_180 caps.JPG
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 caplet contains : calcium 10mg • store below 77 o F (25 o C) • protect contents from humidity • keep tightly closed
Additional information found on label TAMPER EVIDENT PACKAGE BOTTLE SEALED WITH PRINTED FOIL UNDER CAP. DO NOT USE IF FOIL IS MISSING OR BROKEN. Distributed by: GSKConsumer Healthcare Warren, NJ 07059 *When Used As Directed. **Based On Laboratory Testing. Individual Results May Vary. Trademarks are owned by or licensed to the GSK group of companies ©2018 GSK or its licensor.
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 • 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.
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 1-800-897-6081
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.
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