{ "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) ADIPIC ACID CALCIUM CARBONATE CROSPOVIDONE (120 .MU.M) FD&C YELLOW NO. 6 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 SILICON DIOXIDE Light orange Caplet RP122" ], "active_ingredient": [ "Active ingredient (in each caplet) Methylcellulose (a non-allergenic fiber) 500mg" ], "purpose": [ "Purpose Bulk-forming laxative" ], "indications_and_usage": [ "Uses ▪ relieves occasional constipation (irregularity) ▪ generally produces a bowel movement in 12 -72 hours. 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 over a period of 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." ], "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 over a period of 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": [ "Ask a doctor before use if you have ▪ a sudden change in bowel habits that persists over a period of 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." ], "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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222." ], "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 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" ], "dosage_and_administration_table": [ "
AgeDoseMaximum Dose
adults & children 12 years of age and overstart 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 dayDo not exceed 6 caplets per day
children under 6 years of ageConsult a physicianConsult a physician
" ], "spl_unclassified_section": [ "Other information ▪ each caplet contains : calcium 18 mg ▪ store at room temperature. ▪ protect contents from humidity ▪ keep tightly closed" ], "inactive_ingredient": [ "Inactive ingredients adipic acid, calcium carbonate, crospovidone, FD&C yellow no. 6 lake, magnesium stearate, microcrystalline cellulose, polysorbate 80, silica. Do not use if printed seal under cap is torn or missing." ], "questions": [ "Questions or comments? 1-866-467-2748" ], "package_label_principal_display_panel": [ "Principal Display Panel DRx Choice® NDC 68163-122-00 Compare to the active Ingredients in Citrucel® Caplets * Methylcellulose Fiber Therapy Gentle and clinically proven effective† Gives you additional fiber to help relieves occasional constipation. Fiber for irregularity that won’t cause excess gas†† 100 Fiber Caplets Manufactured by: Raritan Pharmaceuticals 8 Joanna Court, East Brunswick, NJ 08816 †When Used as Directed ††Based On Laboratory Testing. Individual Results May Vary. *This product is not manufactured or distributed by GlaxoSmithKline, the owner of the registered trademark Citrucel® Caplets. DRx Choice fiber therapy methylcellulose 100 Caplets" ], "set_id": "5e5749f7-074e-4bbc-9f33-5090e603fdb4", "id": "72ddac8a-c9e3-4928-8e5c-832f8b905bcd", "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": [ "68163-122" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METHYLCELLULOSE (4000 MPA.S)" ], "rxcui": [ "198750" ], "spl_id": [ "72ddac8a-c9e3-4928-8e5c-832f8b905bcd" ], "spl_set_id": [ "5e5749f7-074e-4bbc-9f33-5090e603fdb4" ], "package_ndc": [ "68163-122-00" ], "is_original_packager": [ true ], "upc": [ "0368163122107" ], "unii": [ "MRJ667KA5E" ] } } ] }