FORMUCARE FIBER LAXATIVE

Dosage form: tablet, film coated
Ingredients: CALCIUM POLYCARBOPHIL 625mg
Labeler: Access Business Group LLC
NDC Code: 10056-477

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.

Access Business Group LLC Fiber Laxative Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Purpose

Bulk-forming laxative

Uses
relieves occasional constipation to help restore and maintain regularity
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
noticed 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 exceed 8 caplets in a 24 hour period unless directed by a doctor

Stop use and ask a doctor if

rectal bleeding occurs or you fail to have a bowel movement after use of this or any other laxative. 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 right away.

Directions
take each dose of this product 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.
may take one to three days to provide full benefit
dosage and results may vary according to diet, exercise, previous laxative use or severity of constipation
adults and children 12 years of age and over: 2 caplets per dose, do not exceed 4 doses per day
children under 12 years of age: ask a doctor

Other information
each caplet contains: calcium 140 mg and magnesium 10 mg
store at 20°-25°C

Inactive ingredients

caramel, crospovidone, hypromellose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

Questions or comments?

1-800-719-9260

Principal Display Panel

Just as Effective as Fiber Powders

Fiber Laxative

CALCIUM POLYCARBOPHIL 625 mg

BULK-FORMING LAXATIVE

GENTLE ENOUGH FOR EVERYDAY USE

NATURAL ACTION OF FIBER

FIBER THERAPY FOR REGULARITY

FORMUCARE FIBER LAXATIVE 
calcium polycarbophil tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-477
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM POLYCARBOPHIL (POLYCARBOPHIL) CALCIUM POLYCARBOPHIL625 mg
Inactive Ingredients
Ingredient NameStrength
CARAMEL 
CROSPOVIDONE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorBROWN (light) Score2 pieces
ShapeCAPSULE (caplet) Size19mm
FlavorImprint CodeL477
Contains    
Packaging
#Item CodePackage Description
1NDC:10056-477-751 BOTTLE in 1 CARTON
190 TABLET, FILM COATED in 1 BOTTLE
2NDC:10056-477-92140 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/27/2000
Labeler - Access Business Group LLC (839830713)

Revised: 12/2012
 
Access Business Group LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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