Promolaxin™ Docusate Sodium Stool Softener

Drug Labeling and Warnings

Drug Details [pdf]

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

• 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

PROMOLAXIN 
docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35356-822(NDC: 27495-012)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	GPI;S1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35356-822-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2011	10/11/2019
2	NDC: 35356-822-00	00 in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2011	12/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/15/2011	10/11/2019

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical DBA Quality Care Products LLC		831276758	repack(35356-822) , relabel(35356-822)

Revised: 11/2019

Document Id: c9ab30e0-e1ee-4d5f-a1b3-84252335a3bb

34390-5

Set id: 005771f0-618d-43af-b211-f8e017a402a6

Version: 5

Effective Time: 20191104

 

Lake Er