Curewell Docusate Sodium Liquid

Manufacturer
RMT HEALTH LLC
Effective date
2026-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
weekly-update
Hydrated at
2026-07-17 21:42:13

Label at a glance#

ProductCurewell Docusate Sodium Liquid
Active ingredientDOCUSATE SODIUM
Label structure14 sections

Indications and uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in 12 to 72 hours

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL-teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50mg

Purpose

OTC - PURPOSE SECTION

Stool Softener Laxative

Uses

INDICATIONS & USAGE SECTION


• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

  • for more than one week unless directed by a doctor

Do not use

OTC - DO NOT USE SECTION

  • for more than one week unless directed by a doctor

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

• have stomach pain, nausea or vomiting
• have a sudden change in bowel habits that persists over a period of 2 weeks
• are presently taking mineral oil

Stop use and ask a doctor if

OTC - ASK DOCTOR/PHARMACIST SECTION

• you have rectal bleeding or fail to have a bowel movement after use of this product. These could be signs of a serious condition.
• a skin rash occurs
• you experience throat irritation

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, seek medical assistance or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well before using
• follow dosing directions below or use as directed by a physician
• do not exceed recommended dose
• must be given in a 6oz to 8oz glass of milk or fruit juice to prevent throat irritation
• may be taken as a single dose or in divided doses

take maximum dose daily until first bowel movement, dosage should then be reduces according to individual response.

AGE

DOSE

Adults and Children 12 years of age and over1 to 6 teaspoonsfuls (5ml-30mL)
Children under 12 years of ageAsk a doctor

Other information

OTHER SAFETY INFORMATION

  • each teaspoon (5ml) contains: sodium 9 mg
  • store at room temperature 15-30°C (59-86°F)
  • protect from excessive heat
  • Pharmacist-Preserve and dispense in a tight, light-resistant container with a child-resistant cap as defined in the UPS
  • TAMPER EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

FD&C red#40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate and sucralose

Question or Comments?

OTC - QUESTIONS SECTION

1-800-540-3765

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385111403163GTIN-13: 0385111403163
EAN-13: 0385111403163
GTIN-12: 385111403163
UPC-A: 385111403163
GTIN storage (14 digits): 00385111403163
doc02705120260624135429-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85111-40385111-403-16

Ingredients#

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

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

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Curewell Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLRMT HEALTH LLC55903043-2a1d-0525-e063-6394a90ae1822026-07-01WarningsExact identifier
ndc (package): 85111-403-16
ndc (product): 85111-403
ndc11 (package): 85111040316
spl id: 55901be3-f1c3-f683-e063-6394a90a25fe
spl set id: 55903043-2a1d-0525-e063-6394a90ae182

Reported adverse events (FAERS/openFDA)#

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