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Calcium Polycarbophil 625 mg by REMEDYREPACK INC.

Dosage form: tablet
Ingredients: CALCIUM POLYCARBOPHIL 625mg
Labeler: REMEDYREPACK INC.
NDC Code: 61786-921

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.

Calcium Polycarbophil 625 mg

Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg

(equivalent to polycarbophil 500 mg)

Purpose

Bulk-Forming Laxative

Uses
  • relieves occasional constipation
  • 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 cuase 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 longer than one week

Ask a doctor before use if you have

  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after using this prodcut

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.

Drug Facts continued on back of label

Directions
  • take caplets with at least 8 ounces (a full glass) of water or other fluid. Taking this prodcut without enough liquid may cause choking. See choking warning.
  • take dose up to 4 times daily
  • do not take more than 8 caplets in 24 hours
  • adults & children 12 years and over: 2 caplets
  • children under 12 years: ask a doctor

Other information
  • each caplet contains: calcium 140 mg
  • store at 15°-30°C (59°-86°F)
  • do not refrigerate
  • protect from humidity

Inactive ingredients carob powder, croscarmellose sodium, HPMC, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide

Questions or comments? call 516-341-0666,

8:30 am - 4:30 pm ET, Monday-Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark FIBERCON®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliablel1labs.com

DRUG: Calcium Polycarbophil 625 mg

GENERIC: Calcium Polycarbophil 625 mg

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-921-02

COLOR: white

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 19 mm

IMPRINT: AP;067

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CALCIUM POLYCARBOPHIL 625mg in 1

INACTIVE INGREDIENT(S):

  • CAROB
  • CELLULOSE, MICROCRYSTALLINE
  • SILICON DIOXIDE
  • CROSCARMELLOSE SODIUM
  • HYPROMELLOSES
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL 1000

CALCIUM POLYCARBOPHIL 625 MG 
calcium polycarbophil 625 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-921(NDC:69618-030)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM POLYCARBOPHIL (POLYCARBOPHIL) CALCIUM POLYCARBOPHIL625 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
CAROB 
SILICON DIOXIDE 
POLYETHYLENE GLYCOL 1000 
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize19mm
FlavorImprint CodeAP;067
Contains    
Packaging
#Item CodePackage Description
1NDC:61786-921-0230 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/06/2016
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2016
 
REMEDYREPACK INC.

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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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