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.
Drug Label Information
Updated November 18, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
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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
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.
When using this product
• do not use for more than 7 days unless directed by a doctor
• do not take more than 8 tablets in a 24-hour period unless directed by a doctor
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Directions
• take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning
• dosage will vary according to diet, exercise, previous laxative use or severity of constipation
• continued use for 1 to 3 days is normally required to provide full benefit
adults and children 12 years and over 2 tablets, 1 to 4 times per day children under 12 years ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark FiberCon®
WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
Distributed by: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
www. Rugbylaboratories.com
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIBER LAX
calcium polycarbophil tablet, film coatedProduct 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 (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)