PROMOLAXIN- docusate sodium tablet 
Unit Dose Services

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.

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Promolaxin™ Docusate Sodium Stool Softener

Active ingredient

Docusate Sodium 100 mg

Purpose

Stool Softener

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

, 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

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

Label Image
PROMOLAXIN 
docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 Code GPI;S1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50436-0102-130 in 1 BOTTLE
2NDC:50436-0102-260 in 1 BOTTLE
3NDC:50436-0102-3100 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/FEIBusiness Operations
Unit Dose Services831995316REPACK(50436-0102)

Revised: 4/2011
Document Id: 39fbd627-211b-48b7-bfb5-df0ab4888762
Set id: 62d4a60c-ea30-4ad0-a552-f76562e665d8
Version: 3
Effective Time: 20110405
 
Unit Dose Services