GENDOSE - FIBER LAXATIVE CAPLETS (77333-120)

Manufacturer
Gendose Pharmaceuticals, LLC
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-10-13 04:03:34

Label at a glance#

ProductFIBER LAXATIVE CAPLETS
Active ingredientCALCIUM POLYCARBOPHIL
Label structure9 sections

Indications and uses

relieves occasional constipation to help restore and maintain regularity this product generally produces bowel movement in 12 to 72 hours

Dosage and administration

• 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. • Adults and children over ...

Storage and handling

• each caplet contains: calcium 125mg • store at room temperature • protect contents from moisture

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Calcium polycarbophil 625 mg
(Equivalent to 500 mg polycarbophil)

Purpose

OTC - PURPOSE SECTION

Bulk-forming laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation to help restore and maintain regularity
  • this product generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

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 persist over a period of 2 weeks

Ask a doctor or pharmacist before use ifyou aretaking 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 ifrectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxatives. These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

in case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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.

• Adults and children over 12 years: 2 caplets per dose; do not take more than 8 caplets in 24 hours unless directed by a doctor.
• children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each caplet contains:calcium 125mg
• store at room temperature
• protect contents from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, caramel color, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Omni(01)00377333120508GTIN-14: 00377333120508
GTIN-12: 377333120508
UPC-A: 377333120508
EAN-13: 0377333120508
GTIN storage (14 digits): 00377333120508
label.jpg

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-120-25EA - Each77333-12000d2b681-b51d-4f79-8e75-ad6a2a4d7f2812022-10-06
77333-120-50EA - Each77333-120f371e8ef-063a-4465-aa81-4f518adc663f12022-10-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77333-12077333-120-25, 77333-120-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-01-08full-release2026-06-01 00:12:00

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e768c1f-3c9e-c128-e063-6294a90a4463e7f3b91b-7942-3e0d-e053-2a95a90a34ee2024-01-08WarningsExact identifier
spl set id: e7f3b91b-7942-3e0d-e053-2a95a90a34ee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.