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Promolaxin by Proficient Rx LP

Dosage form: tablet
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Proficient Rx LP
NDC Code: 63187-125

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 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.

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

Repackaged by: Proficient Rx LP, Thousand Oaks, CA 91320

Package/Label Principal Display Panel

Physician's Science and Nature, Inc.

NDC 63187-125-00

Promolaxin™

Docusate Sodium

Stool Softener

100 mg Each

100 Tablets

Bottle Label

Bottle Label

PROMOLAXIN 
docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-125(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:63187-125-00100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/15/2011
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079196022RELABEL(63187-125), REPACK(63187-125)

Revised: 06/2014
 
Proficient Rx LP

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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