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Promolaxin by Unit Dose Services

Dosage form: tablet
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Unit Dose Services
NDC Code: 50436-0102

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Promolaxin™ Docusate Sodium Stool Softener

Active ingredient

Docusate Sodium 100 mg

Purpose

Stool Softener

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

Warnings

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

Ask a doctor before use if you have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

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.

Directions

Adults andchildren 12 yearsof age and older:

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

Children under12 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.

Questions?

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

please contact 714-875-6316.

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

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

PROMOLAXIN (DOCUSATE SODIUM) TABLET
PROMOLAXIN 
docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-0102(NDC:27495-012)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STARCH, CORN 
SILICON DIOXIDE 
SODIUM BENZOATE 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeGPI;S1
Contains    
Packaging
#Item CodePackage Description
1NDC:50436-0102-130 TABLET in 1 BOTTLE
2NDC:50436-0102-260 TABLET in 1 BOTTLE
3NDC:50436-0102-3100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/15/2011
Labeler - Unit Dose Services (831995316)
Registrant - Unit Dose Services (831995316)
Establishment
NameAddressID/FEIOperations
Unit Dose Services831995316REPACK(50436-0102)

 
Unit Dose Services

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Medically reviewed on Apr 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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