FIBER LAX- calcium polycarbophil tablet, film coated 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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0339-Rugby

Drug Facts

Active ingredient (in each tablet)
Calcium polycarbophil 625 mg
(equivalent to polycarbophil 500 mg)

Purpose

Purpose
Bulk-forming laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

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

Stop use and ask a doctor if

• you fail to have a bowel movement after use or 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 (1-800-222-1222) right away.

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 over2 tablets, 1 to 4 times per day
children under 12 yearsask a doctor

Other information

• each tablet contains: calcium 140 mg

• do not use if printed seal under cap is torn or missing
• store in a dry place at 15° – 30°C (59° – 86°F).

• protect contents from moisture

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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Fiber Lax

GENERIC: Calcium Polycarbophil

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-1610-0

COLOR: white

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 19 mm

IMPRINT: CPC;339

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CALCIUM POLYCARBOPHIL 625mg in 1

INACTIVE INGREDIENT(S):

  • CARAMEL
  • CROSPOVIDONE
  • HYPROMELLOSES
  • TALC
  • MAGNESIUM STEARATE
  • CELLULOSE, MICROCRYSTALLINE
  • LIGHT MINERAL OIL
  • POLYETHYLENE GLYCOL 400
  • SILICON DIOXIDE
  • SODIUM LAURYL SULFATE
  • STEARIC ACID

MM1

FIBER LAX 
calcium polycarbophil tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1610(NDC:0536-4306)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL625 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (Off-white) Score2 pieces
ShapeOVALSize19mm
FlavorImprint Code CPC;339
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-1610-030 in 1 BLISTER PACK; Type 0: Not a Combination Product10/29/201810/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/29/201810/13/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023
Document Id: 079f4aa1-a841-9d25-e063-6394a90a8a3b
Set id: e691a39c-6a2b-46cc-ba1a-ae90ba1a6d8a
Version: 8
Effective Time: 20231013
 
REMEDYREPACK INC.