PROMOLAXIN- docusate sodium tablet 
Lake Erie Medical DBA Quality Care Products LLC

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 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

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

Image of Label

Image of Label

PROMOLAXIN 
docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:35356-822(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 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
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:35356-822-6060 in 1 BOTTLE
2NDC:35356-822-0000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/15/2011
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Lake Erie Medical DBA Quality Care Products LLC831276758repack(35356-822), relabel(35356-822)

Revised: 6/2013
Document Id: 95de3bec-31b0-440c-8e26-fb4006a54e72
Set id: 005771f0-618d-43af-b211-f8e017a402a6
Version: 2
Effective Time: 20130606
 
Lake Erie Medical DBA Quality Care Products LLC