Label: FIBER LAX- calcium polycarbophil tablet, film coated
- NDC Code(s): 0536-4306-05, 0536-4306-08, 0536-4306-11
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated May 18, 2020
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- Drug Facts
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
- noticed a sudden change in bowel habits that lasts over two weeks
Ask a doctor or pharmacist before use if you are
taking any other drug. Take Fiber-Lax two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop use and ask a doctor if
- you have rectal bleeding
- you fail to have a bowel movement after using this product.
These may indicate a serious condition.
Take Fiber-Lax 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.
- do not take more than 4 doses in 24 hours
- adults & children 12 years and over: 2 captabs 1 to 4 times a day
- children under 12 years: ask a doctor
- each captab contains: calcium 140 mg
- store below 30˚C (86˚F) • do not refrigerate • protect from humidity
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
calcium polycarbophil tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-4306 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL 625 mg Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) HYPROMELLOSES (UNII: 3NXW29V3WO) TALC (UNII: 7SEV7J4R1U) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (Off-white) Score 2 pieces Shape OVAL Size 19mm Flavor Imprint Code CPC;339 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-4306-08 2 in 1 CARTON 09/01/2010 1 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0536-4306-11 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2010 3 NDC:0536-4306-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/01/2010 Labeler - Rugby Laboratories (079246066)