promolaxin™ docusate sodium stool softener

promolaxin™ docusate sodium stool softener
SPL v1
SPL
SPL Set ID 9d94a91b-638b-41e5-81e0-cd8c13bdfdb8
Route
oral
Published
Effective Date 2012-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (100 mg)
Inactive Ingredients
hypromelloses croscarmellose sodium anhydrous dibasic calcium phosphate magnesium stearate cellulose, microcrystalline polyethylene glycols starch, corn silicon dioxide sodium benzoate stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: GPI;S1 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
otc monograph not final active Since 2011-04-15
Purpose

Stool Softener

Description

Docusate Sodium 100 mg

Medication Information

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

Stool Softener

Directions

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
  • 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

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

Description

Docusate Sodium 100 mg

Questions?

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

Section 42229-5

Relabeling and Repackaging by:

STAT Rx USA LLC

Gainesville, GA 30501

Do Not Use
  • 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
Active Ingredient

Docusate Sodium 100 mg

Stop Use and Ask A Doctor If
  • 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

ask a doctor before use.

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Package Label Promolaxin 100 Mg Tablets

Structured Label Content

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

Stool Softener

Directions

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 (Other information)
  • 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 ingredients)

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

Questions?

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

Section 42229-5 (42229-5)

Relabeling and Repackaging by:

STAT Rx USA LLC

Gainesville, GA 30501

Do Not Use (Do not use)
  • 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
Active Ingredient (Active ingredient)

Docusate Sodium 100 mg

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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 (If pregnant or breast-feeding)

ask a doctor before use.

Keep Out of Reach of Children. (Keep out of Reach of Children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Package Label Promolaxin 100 Mg Tablets (PACKAGE LABEL - PROMOLAXIN 100 MG TABLETS)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:31.456827 · Updated: 2026-03-14T22:53:16.318838