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Promolaxin

Aidarex Pharmaceuticals LLC

Promolaxin™ Docusate Sodium Stool Softener


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Docusate Sodium 100 mg

Purpose

Stool Softener

Promolaxin Uses

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

Warnings

  • 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
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
  • you have rectal bleeding
  • you fail to have a bowel movement after use

    These could be signs of a serious condition.

ask a doctor before use.

  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.

  • 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.

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:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880

Package/Label Principal Display Panel

NDC 33261-0796-00

Promolaxin™

Docusate Sodium

Stool Softener

100 mg Each

100 Tablets

Promolaxin

Promolaxin

Docusate sodium TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33261-796(NDC:27495-012)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
STARCH, CORN
SILICON DIOXIDE
SODIUM BENZOATE
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 11 mm GPI;S1 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33261-796-00 100 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2011-04-15


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Be sure to consult your doctor before taking any medication!
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