FIBER-CAPS STIMULANT FREE FIBER LAXATIVE- calcium polycarbophil capsule 
American Health Packaging

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.

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Fiber-Caps



Stimulant Free Fiber Laxative

Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Purpose

Bulk-forming laxative

Uses

relieves:

  • constipation
  • helps restore & maintain regularity
  • promotes normal function of the bowel
  • this product 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.

Ask a doctor before use if you have:

  • abdominal pain, nausea or vomiting
  • difficulty in swallowing
  • 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 this product 2 or more hours before or after other drugs. All 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 caplets in a 24 hour period unless directed by a doctor

Stop use and ask a doctor if

  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have a bowel movement after use
  • rectal bleeding occurs

Keep out of the reach of children.

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

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 over 12 years

2 caplets, 1 to 4 times a day

children under 12 years

ask a doctor

Other information

  • each caplet contains: calcium 135 mg
  • for your protection do not use product if blister is torn or broken
  • store at room temperature
  • protect contents from moisture

Inactive ingredients

calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate.

The drug product contained in this package is from NDC # 24385-125, AmerisoureBergen distributed for Good Neighbor Pharmacy®.

Distributed by: American Health Packaging, 2550 John Glenn Avenue, Suite A, Columbus, Ohio 43217

096032
Rev. 09/2015OS

Principal Display Panel

Fiber-Caps Laxative Carton

NDC 68084-960-32

Fiber-Caps
Stimulant Free
Fiber Laxative

20 Caplets (5 x 4)

The drug product contained in this package is from
NDC # 24385-125, AmerisoureBergen distributed
for Good Neighbor Pharmacy®.

Distributed by: American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, Ohio 43217

096032
Rev. 09/2015OS

Package/Label Display Panel – Blister

Fiber-Caps Laxative Blister

Fiber-Caps
Stimulant Free Fiber
Laxative Caplet

Calcium polycarbophil 625 mg
equivalent to 500 mg
polycarbophil

Choking Warning! See
Carton Label for complete
usage information

FIBER-CAPS  STIMULANT FREE FIBER LAXATIVE
calcium polycarbophil capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68084-960(NDC:24385-125)
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
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARAMEL (UNII: T9D99G2B1R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
Colorwhite (off-white) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code G147
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68084-960-3220 in 1 BOX, UNIT-DOSE11/02/201507/31/2018
1NDC:68084-960-331 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/01/201507/31/2018
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIBusiness Operations
American Health Packaging929561009repack(68084-960)

Revised: 8/2017
 
American Health Packaging