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FIBER-LAX(CALCIUM polycarbophil)
2015-05-22 12:29:50 来源: 作者: 【 】 浏览:366次 评论:0
FIBER LAX-calcium polycarbophil tablet, film coated 
Rugby Laboratories 

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 eva luated whether this product complies.

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Fiber-Lax Calcium Polycarbophil

 

 

Drug Facts

 

Active ingredient

(in each captab)

Calcium polycarbophil 625 mg

 

Purpose

Bulk-Forming Laxative

(equivalent to polycarbophil 500 mg)

 

Uses

  • relieves occasional constipation
  • generally produces bowel movement in 12 to 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.

 

Do not use

longer than one week

 

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.

 

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

 

 

Directions

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

Other information

  • each captab contains: calcium 140 mg
  • store below 30˚C (86˚F) • do not refrigerate • protect from humidity

 

Inactive ingredients

Caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid

Questions or comments?

Call 1-800-645-2158, 9 am - 5 pm ET, Monday – Friday

TAMPER EVIDENT: DO NOT USE IF BLISTER SEAL IS BROKEN OR DAMAGED

*Rugby Laboratories, Inc. is not affiliated with the owner of the trademark FiberCon®.

Fiber-Lax is distributed by Rugby Laboratories, Inc.

Rugby®
Duluth, Georgia 30097
www. Rugbylaboratories.com

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

e691924b-figure-01
FIBER LAX 
calcium polycarbophil tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-4306
Route of Administration ORAL DEA Schedule     
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: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
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    
1   30 in 1 BLISTER PACK    
2 NDC:0536-4306-11 90 in 1 BOTTLE    
3 NDC:0536-4306-05 500 in 1 BOTTLE    
 
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 (109178264)
Registrant - Contract Pharmacal Corp (968334974)
Establishment
Name Address ID/FEI Business Operations
Contract Pharmacal Corp   968334974 MANUFACTURE(0536-4306)  
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