{ "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": "2026-10-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "DRx Choice 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" ], "active_ingredient": [ "Active ingredient (in each rounded tablespoon) Methylcellulose (a non-allergenic fiber) 2g" ], "purpose": [ "Purpose Bulk-forming fiber laxative" ], "indications_and_usage": [ "Uses ▪ relieves occasional constipation (irregularity) ▪ generally produces a bowel movement 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 ▪ 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." ], "ask_doctor_or_pharmacist": [ "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": [ "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": [ "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 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 physician" ], "dosage_and_administration_table": [ "
AgeDose
adults & children 12 years of age and overstart with 1 rounded tablespoon. Increase as needed, 1 rounded tablespoon at a time, up to 3 times per day.
children 6 - 11 years of agestart with 2 level teaspoons. Increase as needed, 2 level teaspoons at a time, up to 3 times per day.
children under 6 years of ageconsult a physician
" ], "spl_unclassified_section": [ "Other information • each rounded tablespoon contains : calcium 85mg and potassium 125mg • each rounded tablespoon contributes 27 calories from maltodextrin • store at room temperature • protect contents from humidity • keep tightly closed" ], "inactive_ingredient": [ "Inactive ingredients Anhydrous citric acid, FD&C yellow #6 lake, flavor, maltodextrin, potassium citrate, silica, sucralose, tricalcium phosphate, Questions or comments? 1-866-467-2748" ], "questions": [ "Questions or comments? 1-866-467-2748" ], "package_label_principal_display_panel": [ "Principal Display Panel DRx Choice® Compare to the Active Ingredient in Citrucel ® Powder* NDC 68163-517-16 Sugar free Soluble fiber therapy 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 Naturally & Artificially Flavored NET WT 16.9 OZ (479g) Directions for use: 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. **When Used As Directed. ***Based On Laboratory Testing. Individual Results may Vary TAMPER EVIDENT: DO NOT USE PRINTED INNER SEAL IS BROKEN OR MISSING GLUTEN FREE *This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Citrucel ® Powder. Manufactured By: Raritan Pharmaceuticals 8 Joana Court, East Brunswick, NJ 08816 DRx Choice FIBER THEREPY METHYCELLULOSE" ], "package_label_principal_display_panel_table": [ "
TAMPER EVIDENT: DO NOT USE PRINTED INNER SEAL IS BROKEN OR MISSING
" ], "set_id": "56c7f197-f01a-4611-a761-cda18da6eed0", "id": "e05e76f9-c391-452e-93eb-82cca563845e", "effective_time": "20260908", "version": "5", "openfda": { "application_number": [ "M007" ], "brand_name": [ "DRx Choice Fiber Therapy" ], "generic_name": [ "METHYLCELLULOSE" ], "manufacturer_name": [ "RARITAN PHARMACEUTICALS INC" ], "product_ndc": [ "68163-517" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METHYLCELLULOSE (4000 MPA.S)" ], "rxcui": [ "1868843" ], "spl_id": [ "e05e76f9-c391-452e-93eb-82cca563845e" ], "spl_set_id": [ "56c7f197-f01a-4611-a761-cda18da6eed0" ], "package_ndc": [ "68163-517-16" ], "is_original_packager": [ true ], "upc": [ "0368163517163" ], "unii": [ "MRJ667KA5E" ] } } ] }