FDA.reportPublic FDA data

Sennosides

Manufacturer
REMEDYREPACK INC.
Effective date
2022-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:05:46

Label at a glance#

ProductSennosides
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

■ relieves occasional constipation (irregularity) ■ generally produces a bowel movement in 6-12 hours

Dosage and administration

■ take preferably at bedtime or as directed by a doctor Age Starting Dosage Maximum Dosage adults and children 12 years of age and over 2 tablets once a day 4 tablet twice a day children 6 to under 12 years 1 tablets once a day 2 tablets once a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purpose

Laxative

Uses

INDICATIONS & USAGE SECTION

■ relieves occasional constipation (irregularity)

■ generally produces a bowel movement in 6-12 hours

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

■ laxative products for longer than 1 week unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ stomach pain

■ nausea

■ vomiting

■ noticed a sudden change in bowel habits that continues over a period of 2 weeks

OTC - STOP USE SECTION

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative.

These may indicate a serious condition.

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.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

■ take preferably at bedtime or as directed by a doctor

AgeStarting DosageMaximum Dosage

adults and children 12 years of age

and over

2 tablets once a day

4 tablet twice a day

children 6 to under 12 years

1 tablets once a day

2 tablets once a day

children 2 to under 6 years

1/2 tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 25 mg
  • each tablet contains: sodium 1 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, talc

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-231-4670 Monday-Friday 9AM-5PM EST

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Sennosides

GENERIC: Sennosides

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-3387-0

NDC: 70518-3387-1

NDC: 70518-3387-2

NDC: 70518-3387-3

COLOR: brown

SHAPE: ROUND

SCORE: No score

SIZE: 9 mm

IMPRINT: 1122;1122

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

ACTIVE INGREDIENT(S):

  • SENNOSIDES 8.6mg in 1

INACTIVE INGREDIENT(S):

  • POLYETHYLENE GLYCOL 400
  • MICROCRYSTALLINE CELLULOSE
  • HYPROMELLOSES
  • MAGNESIUM STEARATE
  • CROSCARMELLOSE SODIUM
  • LIGHT MINERAL OIL
  • TALC
  • MALTODEXTRIN
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Remedy_LabelRemedy_Label

MM2MM2

MM3MM3

MM4MM4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3387-02024-01-30C16284748780-11030e365-4389-111a-e063-dadaa90a10e21122- Cardinal
70518-3387-22024-01-30C16284748780-11030e365-4389-111a-e063-dadaa90a10e21122- Cardinal

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3387SENNOSIDES TABLET, FILM COATED [REMEDYREPACK INC.]1Legacy NDC20220318_0da6311d-9b6f-408f-855a-8dc069fc4c4f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0447-1EA - Each70000-0447b7bcd123-dc74-4738-b202-e32094104ce012020-07-13
70000-0447-2EA - Each70000-044715aaad9c-4017-4126-b306-ff86cb7aca4d12019-08-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-338770518-3387-1, 70518-3387-0, 70518-3387-3, 70518-3387-2
70000-0447

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
LIGHT MINERAL OILN6K5787QVPIACT
TALC7SEV7J4R1UIACT
MALTODEXTRIN7CVR7L4A2DIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
SENNOSIDES3FYP5M0IJXACTIB

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
da69d452-61fd-45cc-e053-2a95a90a36f20da6311d-9b6f-408f-855a-8dc069fc4c4f2022-03-17WarningsExact identifier
spl id: da69d452-61fd-45cc-e053-2a95a90a36f2
spl set id: 0da6311d-9b6f-408f-855a-8dc069fc4c4f

Reported adverse events (FAERS/openFDA)#

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