Search by Drug Name or NDC

NDC 63187-0125-00 Promolaxin 100 mg/1 Details

Promolaxin 100 mg/1

Promolaxin is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is DOCUSATE SODIUM.

MedlinePlus Drug Summary

Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.

Related Packages: 63187-0125-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	63187-0125
Product ID	63187-125_68285586-9186-4ffb-9142-924001aed536
Associated GPIs	46500010300305
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Promolaxin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Docusate sodium
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	Proficient Rx LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0125-00 (63187012500)

Pricing Information	N/A
NDC Package Code	63187-125-00
Billing NDC	63187012500
Package	100 TABLET in 1 BOTTLE (63187-125-00)
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9ff570c5-1d0e-47bb-aea2-347c7b24ca68 Details

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

INGREDIENTS AND APPEARANCE

PROMOLAXIN

docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-125(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:63187-125-00	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

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

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-125) , RELABEL(63187-125)

Revised: 1/2021

Document Id: 68285586-9186-4ffb-9142-924001aed536

Set id: 9ff570c5-1d0e-47bb-aea2-347c7b24ca68

Version: 3

Effective Time: 20210101