FIBER LAXATIVE - calcium polycarbophil tablet 
Geri-Care Pharmaceutical Corp

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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Active ingredient (in each caplet)

Calcium Polycarbophil 625 mg

(equivalent to 500 mg polycarbophil)

Purpose

Bulk-forming laxative

Uses

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
• for more than 1 week unless directed by a doctor

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

• all laxatives may affect how other drugs work.

Stop use and ask a doctor if

• you have rectal bleeding

• you have no bowel movement within 3 days

• 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

• do not exceed recommended dose

• take each dose with at least 8 ounces (a full glass) of fluid; taking this product without enough liquid may cause choking; see choking warning

• do not take this product within 2 hours before or after taking any other drug

adults and children 12
years of age and older
Starting dose: 2 caplets once a day
Maximum dose: 2 caplets four times a day
Starting dose: 2 caplets once a day
Maximum dose: 2 caplets four times a day
consult a doctor

Other information

each caplet contains: calcium 125 mg

• store at controlled room temperature, 68°F-77°F (20°C-25°C)

• protect contents from moisture

• for institutional use only

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

caramel color, croscarmellose sodium, hypromellose, microcrystalline cellulose, PEG, silica, talc

Package Label

GERICARE

NDC 57896-449-09
Fiber Laxative
Calcium Polycarbophil

• Relieves Constipation

• Promotes Regularity

90 Caplets

625 mg Each

Compare to active ingredient

in FiberCon®*

Fiber Laxative label

FIBER LAXATIVE 
calcium polycarbophil tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-449
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
CARAMEL (UNII: T9D99G2B1R)  
Product Characteristics
Color brown (Off white with dark brown specks) Score no score
Shape OVAL (Caplet) Size 20mm
Flavor Imprint Code AZ221
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57896-449-09 90 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 01/01/2004
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 12/2013
Document Id: 84f15a32-a52d-450f-a0b3-85cd03faf947
Set id: 26ba6938-c31c-4fe1-aacb-28ba30368df3
Version: 1
Effective Time: 20131218
 
Geri-Care Pharmaceutical Corp