Promolaxin

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2020-08-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:16:59

Label at a glance#

ProductPromolaxin
Active ingredientDOCUSATE SODIUM
Label structure13 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age and older: Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor. Children under 12 years of age: Consult a doctor before use.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • laxative products for longer than one week unless directed to do so by a doctor
  • if you are presently taking mineral oil unless told to do so by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

Keep out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:

Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor.

Children under 12 years of age:

Consult a doctor before use.

Other information

SPL UNCLASSIFIED SECTION

  • Each tablet contains: Calcium 40 mg
  • Each tablet contains: Sodium 10 mg
  • Store at room temperature.
  • Do not use if imprinted safety seal is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid.

Questions?

OTC - QUESTIONS SECTION

If you have any questions or comments, or to report an adverse event,

please contact 714-875-6316.

Manufactured for: Physician's Science and Nature, Inc.

220 Newport Center Drive 11-634, Newport Beach, CA 92660

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Physician's Science and Nature, Inc.

NDC 68788-9440-1

Promolaxin™

Docusate Sodium

Stool Softener

100 mg Each

100 Tablets

Relabeled By: Preferred Pharmaceuticals Inc.

Promolaxin 100mg
Promolaxin 100mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-9440-1EA - Each68788-9440144b4266-8192-4e78-8c8e-392500794c2f12018-09-05
27495-012-01EA - Each27495-0125f0510fa-a0b3-4e9b-a9e1-ce7be23ce5f612012-07-24

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
68788-944068788-9440-1
27495-012

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

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
afc56afb-c788-43f3-bae3-6803abf7d50b86c0dc35-8a01-4b49-83e9-8da185a454cc2021-09-02WarningsExact identifier
spl set id: 86c0dc35-8a01-4b49-83e9-8da185a454cc

Reported adverse events (FAERS/openFDA)#

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