Fiber Caplets

Fiber Caplets
SPL v7
SPL
SPL Set ID ee06868b-f741-8da2-e053-2a95a90a9772
Route
ORAL
Published
Effective Date 2025-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polycarbophil (625 mg)
Inactive Ingredients
Caramel Silicon Dioxide Sodium Lauryl Sulfate Crospovidone Microcrystalline Cellulose Hypromelloses Magnesium Stearate Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance
Imprint: XH;C1 Shape: oval Color: white Size: 19 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-12

Description

Active ingredient (in each caplet) Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Purpose

Bulk-forming laxative


Medication Information

Warnings and Precautions

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.

Purpose

Bulk-forming laxative

Description

Active ingredient (in each caplet) Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1

Keep out of reach of children.

Section 51727-6

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

Section 51945-4

Fiber Caplets

Compare to the active ingredient in FiberCon ®

BULK-FORMING / FIBER LAXATIVE

  • GENTLE RELIEF OF CONSTIPATION
  • WON’T CAUSE GAS OR BLOATING
  • EFFECTIVE AS FIBER POWDERS

Distributed by: Xinhua Health Technology(HongKong)Co., Limited

Room 29 block a 13/f metropolitan fty & wh bldg 30-32chaiwan kok st tsuen wannt

90 Caplets

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 years 2 caplets, 1 to 4 times per day
children under 12 years ask a doctor

Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

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

Questions Or Comments?

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

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.

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.


Structured Label Content

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Fiber Caplets

Compare to the active ingredient in FiberCon ®

BULK-FORMING / FIBER LAXATIVE

  • GENTLE RELIEF OF CONSTIPATION
  • WON’T CAUSE GAS OR BLOATING
  • EFFECTIVE AS FIBER POWDERS

Distributed by: Xinhua Health Technology(HongKong)Co., Limited

Room 29 block a 13/f metropolitan fty & wh bldg 30-32chaiwan kok st tsuen wannt

90 Caplets

Purpose

Bulk-forming laxative

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 years 2 caplets, 1 to 4 times per day
children under 12 years ask a doctor

Drug Facts

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)

Other Information (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

Questions Or Comments? (Questions or comments?)

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

When Using This Product (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 (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.

Ask A Doctor Before Use If You Have (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 (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.


Advanced Ingredient Data


Raw Label Data

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