Plus Pharma Docusate Sodium 100 mg Tablets

Manufacturer
Gemini Pharmaceuticals, Inc. dba Plus Pharma
Effective date
2020-11-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 23:07:31

Label at a glance#

ProductPlusPHARMA Stool Softener
Active ingredientDOCUSATE SODIUM
Label structure11 sections

Storage and handling

Other information each tablet contains: c alcium 40 mg, s odium 10 mg store at room temperature in a dry place

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Docusate Sodium 100 mg

OTC - PURPOSE SECTION

Purpose

Stool softener

INDICATIONS & USAGE SECTION

Uses

  • for relief of occasional constipation (irregularity)
  • this product generally produces a bowel movement within 12 to 72 hours

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use if you are presently taking mineral oil unless told to do so by a doctor.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for longer than one week

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years and older:
  • take 1 tablet as needed, not to exceed 3 tablets daily, or as directed by a doctor
  • tablets may be swallowed whole or crushed and mixed with food
  • children under 12 years: consult a doctor before use

STORAGE AND HANDLING SECTION

Other information

  • each tablet contains: c alcium 40 mg, s odium 10 mg
  • store at room temperature in a dry place

INACTIVE INGREDIENT SECTION

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, silica, sodium benzoate, stearic acid

OTC - QUESTIONS SECTION

Questions? If you have any questions or comments, or to report an adverse event, please contact (800)-795-9775.

SPL UNCLASSIFIED SECTION

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

Distributed By:

Plus Pharma

Commack, NY 11725

Manufactured in a GMP facility in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PlusPHARMA

NDC 51645-750-01

DOCUSATE SODIUM 100 mg

Stool Softener

Relieves Occasional Constipation (Irregularity)

Crushable Tablets for Ease of Administration

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

*Compare to the Active Ingredient in Colace®

*Plus Pharma is not affiliated with the owner of the registered trademark Colace®

100 TABLETS • 100 mg each

SS 100 mg 100-ctSS 100 mg 100-ct

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51645-750-01EA - Each51645-750961d4eee-d37a-40be-9806-bb97c318caf412021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA05
DOCUSATEACTIVE MOIETYM7P27195AG5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH485
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I305
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU45
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP5

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
51645-75051645-750-99, 51645-750-01, 51645-750-10

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 258 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, DELAYED RELEASE PARTICLES / ORAL64 mgExact identifier — unii candidate
22 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPCAPSULE / ORAL400 mgExact identifier — unii candidate
10 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, DELAYED RELEASE PELLETS / ORAL127 mgExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL47 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPCAPSULE, EXTENDED RELEASE / ORAL51 mgExact identifier — unii candidate
10 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FOR SUSPENSION / ORAL1875 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, DELAYED RELEASE / ORAL79 mgExact identifier — unii candidate
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPPASTE, DENTIFRICE / DENTAL51 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOAP / TOPICAL6 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSHAMPOO / TOPICAL3 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii candidate
27 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii candidate
27 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, EXTENDED RELEASE / ORAL1036 mgExact identifier — unii candidate
10 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGEL / RECTAL348 mgExact identifier — unii candidate
27 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates

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
b3db5c6e-199b-d0ec-e053-2995a90a968ceb1b3d99-ddda-4ae2-b67e-8fac03b31cae2020-11-11WarningsExact identifier
spl id: b3db5c6e-199b-d0ec-e053-2995a90a968c
spl set id: eb1b3d99-ddda-4ae2-b67e-8fac03b31cae

Reported adverse events (FAERS/openFDA)#

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