FDA.reportPublic FDA data

Senna Laxative

Manufacturer
Healthlife of USA | Time Cap Laboratories, Inc.
Effective date
2017-12-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:06:06

Label at a glance#

ProductSenna Laxative
Active ingredientSENNOSIDES
Label structure12 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 or older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years  1 tablet once a day  2 tablets twice a day  children 2 to under 6 years  1/2 tablet once a day  1 tablet twice a day  children under 6 years  ask a doctor  ask a doctor 

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have 

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 week

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Overdose warning

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take preferably at bedtime or as directed by a doctor
 agestarting dosage  maximum dosage
 adults and children 12 years of age or older2 tablets once a day4 tablets twice a day
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day 
children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day 
children under 6 years ask a doctor ask a doctor 

Other information

SPL UNCLASSIFIED SECTION

  • store at 20-25°C (68-77°)
  • each tablet contains: calcium 25mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, liquid paraffin, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil*, silicon dioxide*,stearic acid*,sodium lauryl sulfate*,talc*,triacetin*

[*contains one or more of these ingredients]

Senna Laxative natural vegetable laxative8.6mg each tablet24 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69517-145-242024-10-18C16284748780-1f386c64a-190a-0266-e053-dadaa90a7c1aSenna Laxative natural vegetable laxative
69517-145-242023-01-30C16284748780-1f386c64a-190a-0266-e053-dadaa90a7c1aSenna Laxative natural vegetable laxative

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-14569517-145-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PARAFFINI9O0E3H2ZEIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TALC7SEV7J4R1UIACT
TRIACETINXHX3C3X673IACT

Source Document#

Source XML · Source PDF

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
24bfe388-e30b-719a-e063-6394a90a57e723910f53-c7f5-4756-b75f-3d47d3e1ad2c2024-10-18WarningsExact identifier
spl set id: 23910f53-c7f5-4756-b75f-3d47d3e1ad2c

Reported adverse events (FAERS/openFDA)#

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