PROMOLAXIN- docusate sodium tablet
Preferred Pharmaceuticals Inc.

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

Package/Label Principal Display Panel

Physician's Science and Nature, Inc.

NDC 68788-9440-1

Promolaxin™

Docusate Sodium

Stool Softener

100 mg Each

100 Tablets

Relabeled By: Preferred Pharmaceuticals Inc.

PROMOLAXIN
docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-9440(NDC:27495-012)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68788-9440-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2018	09/02/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	07/13/2018	09/02/2021

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-9440)

Revised: 9/2021

Document Id: afc56afb-c788-43f3-bae3-6803abf7d50b

Set id: 86c0dc35-8a01-4b49-83e9-8da185a454cc

Version: 4

Effective Time: 20210902

Preferred Pharmaceuticals Inc.