Promolaxin

Manufacturer: STAT Rx USA LLC | PSS World Medical Inc.
Effective date: 2012-09-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:33:05

Label at a glance#

ProductPromolaxin

Active ingredientDOCUSATE SODIUM

Label structure14 sections

Indications and uses

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

Dosage and administration

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.

Contacts and useful links#

PhoneLabel contact714-875-6316

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

Keep out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic Acid.

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Relabeling and Repackaging by:

STAT Rx USA LLC

Gainesville, GA 30501

PACKAGE LABEL - PROMOLAXIN 100 MG TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROMOLAXIN 100 MG 42549 LABEL Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1099279	docusate sodium 100 MG Oral Tablet	PSN	1
1099281	Promolaxin 100 MG Oral Tablet	PSN	1
1099281	docusate sodium 100 MG Oral Tablet [Promolaxin]	SBD	1
1099279	docusate sodium 100 MG Oral Tablet	SCD	1
1099279	DOSS Sodium 100 MG Oral Tablet	SY	1
1099281	DOSS Sodium 100 MG Oral Tablet [Promolaxin]	SY	1
1099281	Promolaxin 100 MG Oral Tablet	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42549-693-71	2019-11-13	C162847	48780-1	97449f38-bc90-f6ea-e053-dbdaa90aa703	Promolaxin™ Docusate Sodium Stool Softener

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42549-693-71	Promolaxin	100 in 1 BOTTLE	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42549-693	PROMOLAXIN (DOCUSATE SODIUM) TABLET [STAT RX USA LLC]	1	1 package rows	20120920_9d94a91b-638b-41e5-81e0-cd8c13bdfdb8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27495-012-01	EA - Each	27495-012	5f0510fa-a0b3-4e9b-a9e1-ce7be23ce5f6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Promolaxin
Docusate sodium
DOCUSATE
HYPROMELLOSES
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
STARCH, CORN
SILICON DIOXIDE
SODIUM BENZOATE
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42549-693	42549-693-71
27495-012

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOCUSATE SODIUM	F05Q2T2JA0	ACTIB
HYPROMELLOSES	3NXW29V3WO	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
STARCH, CORN	O8232NY3SJ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 263 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	PASTE, DENTIFRICE / DENTAL	48.36 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE PELLETS / ORAL		127 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, EXTENDED RELEASE / ORAL	119.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	PASTILLE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SHAMPOO / TOPICAL	3 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	GRANULE / ORAL		150 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, CHEWABLE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	PELLET / ORAL		162 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, EXTENDED RELEASE / ORAL		360 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	221 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, COATED PELLETS / ORAL		456 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / ORAL		2240 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	CAPSULE, EXTENDED RELEASE / ORAL	301.7 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, EXTENDED RELEASE / ORAL		392 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SYSTEM / TOPICAL		54 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
86642628-4094-4d67-b46d-188b210bb0a8			9d94a91b-638b-41e5-81e0-cd8c13bdfdb8	2012-09-19	Warnings	Exact identifier spl id: 86642628-4094-4d67-b46d-188b210bb0a8 spl set id: 9d94a91b-638b-41e5-81e0-cd8c13bdfdb8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.