{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-18", "results": { "skip": 0, "limit": 1, "total": 19 } }, "results": [ { "spl_product_data_elements": [ "FIBER THERAPY methylcellulose METHYLCELLULOSE (4000 MPA.S) METHYLCELLULOSE (4000 MPA.S) CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 MALTODEXTRIN POTASSIUM CITRATE SILICON DIOXIDE SUCROSE" ], "active_ingredient": [ "Active ingredient (in each 19g adult dose/ rounded tablespoon) Methylcellulose 2g (a non-allergenic fiber)" ], "purpose": [ "Purpose Bulk-forming fiber laxative" ], "indications_and_usage": [ "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" ], "warnings": [ "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" ], "ask_doctor_or_pharmacist": [ "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": [ "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": [ "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." ], "dosage_and_administration": [ "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 half the adult dose in 8 ounces of water once daily. children under 6 years of age ask a doctor" ], "dosage_and_administration_table": [ "
AgeDose
adults & children above 12 years of age and overone 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 agehalf the adult dose in 8 ounces of water once daily.
children under 6 years of ageask a doctor
" ], "spl_unclassified_section": [ "Other information • each adult dose contains approximately • 3 mg of sodium • 105 mg 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" ], "inactive_ingredient": [ "Inactive ingredients citric acid, FD&C yellow 6 aluminum lake, maltodextrin, flavor (natural and artificial), potassium citrate, silica, sucrose," ], "questions": [ "Questions or comments? 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 Relabeled By: Preferred Pharmaceuticals Inc. Livonia, MI 48152, USA Relabeled By: Preferred Pharmaceuticals Inc. 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. Image of pouring water into glass Image of stirring water after adding Citrucel" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 68788-7995-4 Compare to the Active Ingredient in CITRUCEL ®* 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 Orange Flavored" ], "set_id": "31033385-7932-448e-8980-11f2e8197eae", "id": "a4a9b13a-7fae-4215-888d-1eac5424df81", "effective_time": "20260416", "version": "6", "openfda": { "application_number": [ "334" ], "brand_name": [ "FIBER THERAPY" ], "generic_name": [ "METHYLCELLULOSE" ], "manufacturer_name": [ "Preferred Pharmaceuticals Inc." ], "product_ndc": [ "68788-7995" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METHYLCELLULOSE (4000 MPA.S)" ], "rxcui": [ "1868843" ], "spl_id": [ "a4a9b13a-7fae-4215-888d-1eac5424df81" ], "spl_set_id": [ "31033385-7932-448e-8980-11f2e8197eae" ], "package_ndc": [ "68788-7995-4" ], "original_packager_product_ndc": [ "0904-5675" ], "unii": [ "MRJ667KA5E" ] } } ] }