TOPCARE FIBER LAXATIVE- calcium polycarbophil tablet, film coated 
Topco Associates LLC

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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Topco 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
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

rectal bleeding occurs or if 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. (1-800-222-1222)

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.
this product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.
 
age
 
recommended dose
 
daily maximum
 
adults and children 12 years of age and over
 
2 caplets once a day
 
up to 4 times a day
 
children under 12 years
 
consult a physician

Other information

each caplet contains: calcium 140 mg and magnesium 10 mg
store at 20-25oC (68-77oF)

Inactive ingredients

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

Questions or comments?

1-888-423-0139

Principal Display Panel

FIBER THERAPY FOR REGULARITY

Fiber Laxative

CALCIUM POLYCARBOPHIL 625 mg

BULK-FORMING LAXATIVE

Gentle Enough for Everyday Use

Natural Action of Fiber

Just as Effective as Fiber Powders

COMPARE TO FIBERCON® active ingredient

Fiber Laxative Label Image
TOPCARE FIBER LAXATIVE 
calcium polycarbophil tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-477
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 Code L477
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-477-7590 in 1 BOTTLE
2NDC:36800-477-92140 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/11/1997
Labeler - Topco Associates LLC (006935977)

Revised: 12/2012
Document Id: 4f9cb525-7c2c-49c8-987b-bc54638cb15d
Set id: 7c83cc9d-008d-4ee6-b91f-44973b2f5d20
Version: 2
Effective Time: 20121206
 
Topco Associates LLC