Docusate Sodium Liquid

Manufacturer: Rij Pharmaceutical Corporation
Effective date: 2018-04-30
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:55:23

Label at a glance#

ProductDocusate Sodium Liquid

Active ingredientDocusate sodium

Label structure9 sections

Indications and uses

prevents / relieves dry hard stool results usually occur 1 to 3 days after the first dose

Dosage and administration

follow dosing directions below or take as directed by doctor must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation may be taken as a single daily dose or in divided doses take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response do not exceed recommended dose shake well before using Adults and children 12 years and over 1 to ...

Label contents#

Full prescribing information#

Active Ingredient (per teaspoonful = 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

prevents / relieves dry hard stool
results usually occur 1 to 3 days after the first dose

Warnings

WARNINGS SECTION

Do not use

when abdominal pain, nausea, or vomiting are present
for more than one week unless directed by a doctor

Ask a doctor before use if you

are taking mineral oil
have noticed a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if

you have no bowel movement within 3 days
you have rectal bleeding
these could be signs of a serious condition
a skin rash occurs
you experience throat irritation

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, seek professional assisstance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

follow dosing directions below or take as directed by doctor
must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation
may be taken as a single daily dose or in divided doses
take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
do not exceed recommended dose
shake well before using

Adults and children 12 years and over	1 to 4 teaspoons (50 to 200 mg)
Children under 12 years of age	ask a doctor

1 teaspoon = 5 mL

TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.

Other information

Store at room temperature 15°-30°C (59°-86°F)
protect from excessive heat
Keep tightly closed
Dispense in tight, light resistant container as defined in the USP
each teaspoon (5 mL) contains: sodium 15 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C Red #33, flavor, parabens, poloxamer, propylene glycol, sodium citrate, sorbitol, sucrose, and water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1245686	docusate sodium 50 MG in 5 mL Oral Solution	PSN	2
1245686	docusate sodium 10 MG/ML Oral Solution	SCD	2
1245686	docusate sodium 10 MG per 1 ML Oral Solution	SY	2
1245686	docusate sodium 100 MG per 10 ML Oral Solution	SY	2
1245686	docusate sodium 150 MG per 15 ML Oral Solution	SY	2
1245686	DOSS Sodium 10 MG/ML Oral Solution	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53807-216-08	2020-01-31	C162847	48780-1	9d75b9d0-50bf-f424-e053-dadaa90a57ce	Drug Facts
53807-216-16	2020-01-31	C162847	48780-1	9d75b9d0-50bf-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53807-216-08	Docusate Sodium Liquid	236 mL in 1 BOTTLE, PLASTIC	LIQUID	236		2
53807-216-16	Docusate Sodium Liquid	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53807-216	DOCUSATE SODIUM LIQUID (DOCUSATE SODIUM) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	2	Legacy NDC, 2 package rows	20180502_c7978ca6-cc76-447b-b7bf-9547f6e49212.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Docusate sodium	ACTIVE INGREDIENT	F05Q2T2JA0	1
Docusate	ACTIVE MOIETY	M7P27195AG	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	1
D&C red no. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
Poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Docusate Sodium Liquid
Docusate sodium
Docusate
anhydrous citric acid
D&C red no. 33
methylparaben
propylparaben
propylene glycol
sodium citrate
water
Poloxamer 407
SUCROSE
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53807-216	53807-216-08, 53807-216-16

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
anhydrous citric acid	XF417D3PSL	IACT
D&C red no. 33	9DBA0SBB0L	IACT
methylparaben	A2I8C7HI9T	IACT
propylparaben	Z8IX2SC1OH	IACT
propylene glycol	6DC9Q167V3	IACT
sodium citrate	1Q73Q2JULR	IACT
water	059QF0KO0R	IACT
Poloxamer 407	TUF2IVW3M2	IACT
SUCROSE	C151H8M554	IACT
SORBITOL	506T60A25R	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 7 · 410 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION, CONCENTRATE / INTRAVENOUS		60 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / RESPIRATORY (INHALATION)		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / TOPICAL	4.35 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
D&C red no. 33	D&C RED NO. 33	9DBA0SBB0L	ELIXIR / ORAL	27.5 mg/5ml		Exact identifier — unii candidate 14 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
D&C red no. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Poloxamer 407	POLOXAMER 407	TUF2IVW3M2	GEL / OPHTHALMIC		1 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CLOTH / TOPICAL	4.2 mg		Exact identifier — unii candidate 61 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		81 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
D&C red no. 33	D&C RED NO. 33	9DBA0SBB0L	SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY, METERED / NASAL	1.2 mg/1ml		Exact identifier — unii candidate 61 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		35 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 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
27f1d997-9032-46d0-9caf-bc487d63bbea			c7978ca6-cc76-447b-b7bf-9547f6e49212	2018-04-30	Warnings	Exact identifier spl id: 27f1d997-9032-46d0-9caf-bc487d63bbea spl set id: c7978ca6-cc76-447b-b7bf-9547f6e49212

Reported adverse events (FAERS/openFDA)#

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