CALCIUM POLYCARBOPHIL- calcium polycarbophil tablet, film coated 
SHANDONG XINHUA PHARMACEUTICAL CO., LTD.

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 Caplets
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 (irregularity)

generally produces bowel movement in 12 to 72 hours

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 two or more hours before or after other drugs. 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 or have rectal bleeding. 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 this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid my 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 years2 caplets, 1 to 4 times per day
children under 12 yearsask a doctor

Other information

each caplet contains: calcium 140 mg

do not use if printed seal under cap is torn or missing store in a dry place at 15° – 30°C (59° – 86°F)
protect contents from moisture

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

Questions or comments?

Call 1-844-374-0016 weekdays 9 AM to 5 PM EST

Fiber Caplets

Compare to the active ingredient in FiberCon ®

BULK-FORMING / FIBER LAXATIVE

Manufactured and Distributed by: Shandong Xinhua Pharmaceutical Co., Ltd. Zibo, Shandong 255086, P.R. China

90 Caplets

updated label

CALCIUM POLYCARBOPHIL 
calcium polycarbophil tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58624-5003
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
CARAMEL (UNII: T9D99G2B1R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CROSPOVIDONE (UNII: 2S7830E561)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
Colorwhite (off white) Score2 pieces
ShapeOVALSize19mm
FlavorImprint Code XH;C1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58624-5003-190 in 1 BOTTLE; Type 0: Not a Combination Product04/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/12/2023
Labeler - SHANDONG XINHUA PHARMACEUTICAL CO., LTD. (653915728)
Registrant - SHANDONG XINHUA PHARMACEUTICAL CO., LTD. (554507599)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Xinhua Pharmaceutical Co., Ltd.554507599manufacture(58624-5003)

Revised: 4/2023
Document Id: fa1d8388-2758-87d2-e053-6294a90ac85d
Set id: ee06868b-f741-8da2-e053-2a95a90a9772
Version: 6
Effective Time: 20230424
 
SHANDONG XINHUA PHARMACEUTICAL CO., LTD.