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| Product NDC Code | 0135-0090 | ||||||||
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| Drug Name | Citrucel |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | POWDER, FOR SOLUTION | ||||||||
| RxCUI drug identifier | 1868843, 1868847 |
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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 heaping tablespoon) CITRUCEL Orange Methylcellulose (a non-allergenic fiber) 2 g
Active ingredient (in each rounded tablespoon) CITRUCEL Sugar Free Methylcellulose (a non-allergenic fiber) 2 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 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 CITRUCEL Orange Age Dose adults and 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 doctor CITRUCEL Sugar Free Age Dose adults and children 12 years of age and over start with 1 rounded tablespoon . Increase as needed, 1 rounded tablespoon at a time, up to 3 times per day. children 6 - 11 years of age start with 2 level teaspoons . Increase as needed, 2 level teaspoons at a time, up to 3 times per day. children under 6 years of age consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (Citrucel Orange) citric acid, dibasic calcium phosphate, FD&C yellow #6 lake, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin, soy lecithin, sucrose, titanium dioxide, tricalcium phosphate
Inactive ingredients (Citrucel Sugar Free) aspartame, dibasic calcium phosphate, FD&C yellow #6 lake, malic acid, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin
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 CITRIC ACID MONOHYDRATE ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C YELLOW NO. 6 MALTODEXTRIN POTASSIUM CITRATE RIBOFLAVIN SUCROSE TITANIUM DIOXIDE TRICALCIUM PHOSPHATE METHYLCELLULOSE (4000 MPA.S) METHYLCELLULOSE (4000 MPA.S) CITRUCEL methylcellulose ASPARTAME ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C YELLOW NO. 6 MALIC ACID MALTODEXTRIN POTASSIUM CITRATE RIBOFLAVIN METHYLCELLULOSE (4000 MPA.S) METHYLCELLULOSE (4000 MPA.S)
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 HALEON Great Taste CITRUCEL METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY Gentle and clinically proven effective* Gives you additional fiber to help relieve occasional constipation Fiber for irregularity that won’t cause excess gas** orange FLAVOR NET WT 30 OZ (850 g) Great Tasting CITRUCEL Orange Citrucel offers these great benefits: Gentle and clinically proven effective to help relieve occasional constipation* Fiber that won't ferment to cause excess gas ** 100% Soluble, gluten-free, non-allergenic fiber *When Used As Directed. **Based On Laboratory Testing. Individual Results May Vary. TAMPER EVIDENT PACKAGE DO NOT USE IF FOIL SEAL IS MISSING OR BROKEN. 211407 211407 Citrucel Orange 30 oz label
Principal Display Panel HALEON Great Taste CITRUCEL METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY Gentle and clinically proven effective* Gives you additional fiber to help relieve occasional constipation Fiber for irregularity that won’t cause excess gas** sugar free ORANGE FLAVOR NET WT 16.9 OZ (479 GRAMS) Great Tasting Orange Flavor CITRUCEL Sugar Free Citrucel offers these great benefits: Gentle and clinically proven effective to help relieve occasional constipation* Fiber that won't ferment to cause excess gas** 100% Soluble, gluten-free, and non-allergenic fiber *When Used As Directed. **Based On Laboratory Testing. Individual Results May Vary. TAMPER EVIDENT PACKAGE DO NOT USE IF FOIL SEAL IS MISSING OR BROKEN. 211406 211406 Citrucel Sugar Free Orange 33 oz label
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 (Citrucel Orange) each heaping tablespoon contains: calcium 80 mg, potassium 105 mg, sodium 10 mg each heaping tablespoon contributes 60 calories from sucrose and maltodextrin store below 25°C (77°F) protect contents from humidity keep tightly closed
Other information (Citrucel Sugar Free) each rounded tablespoon contains: calcium 80 mg, potassium 120 mg, sodium 15 mg each rounded tablespoon contributes 30 calories from maltodextrin store below 25°C (77ºF) protect contents from humidity keep tightly closed Phenylketonurics: CONTAINS PHENYLALANINE 48.6 mg per adult dose
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.
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? (Citrucel Orange) 1-800-897-6081 Great Tasting CITRUCEL Orange DIRECTIONS FOR USE (NO SCOOP DOSING): 1. Fill glass with at least 8 oz. of cold water. 2. Measure heaping tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly. Image_pouring water_into glass.jpg Image_stirring water_after Citrucel.jpg
Questions or comments? (Citrucel Sugar Free) 1-800-897-6081 DIRECTIONS FOR USE (NO SCOOP DOSING): 1. Fill glass with at least 8 oz. of cold water. 2. Measure rounded tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly. Image_pouring water_into glass.jpg Image_stirring water_after Citrucel.jpg
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 (CITRUCEL Orange) constipation lasts more than 7 days you have rectal bleeding you fail to have a bowel movement after use These could be signs of a serious condition.
Stop use and ask a doctor if (CITRUCEL Sugar Free) constipation lasts more than 7 days you have rectal bleeding you fail to have a bowel movement after use 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 (CITRUCEL Orange) constipation lasts more than 7 days you have rectal bleeding you fail to have a bowel movement after use These could be signs of a serious condition. Stop use and ask a doctor if (CITRUCEL Sugar Free) constipation lasts more than 7 days you have rectal bleeding you fail to have a bowel 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.
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