Drug Facts

Set ID
30b9bbf3-0a64-41de-bfb4-5c8c257cc3e8
Manufacturer
United Natural Foods, Inc. dba UNFI
Effective date
2024-05-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:53

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

Uses

relieves occasional constipation (irregularity) generally produces a bowel movement within 6- 12 hours.

Warnings

Warnings

Directions And Dosage

Directions

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 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 tablets once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Other Label Information

Other information

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

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil*, silicon dioxide*, stearic acid*, sodium lauryl sulfate*, talc*, triacetin* *contains one or more of these ingredients

Questions or comments?

Call toll free 1-877-932-7948

Principal Display Panel

compare to Senokot® active ingredient† regular strength senna laxative sennosides 8.6 mg natural vegetable laxative ingredient Tablets †This product is not manufactured or distributed by Aniro Health L.P., distributor of Senokot®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA

Products

NDC Codes

Ingredients

NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TRIACETINXHX3C3X673IACT

Complete SPL Sections

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity) generally produces a bowel movement within 6- 12 hours.

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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 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 tablets once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil*, silicon dioxide*, stearic acid*, sodium lauryl sulfate*, talc*, triacetin* *contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-932-7948

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

compare to Senokot® active ingredient† regular strength senna laxative sennosides 8.6 mg natural vegetable laxative ingredient Tablets †This product is not manufactured or distributed by Aniro Health L.P., distributor of Senokot®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUALINE Senna Laxative

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
25275

Legacy File Index

FolderFileDate
otc54bd4f0e-19f5-48d6-8b62-2e6d73afc740.xml2024-05-24
otc8e2704ee-bda6-4ecb-8a18-5623e739f945.xml2022-12-06
otcb59af047-46b2-4a02-b076-fc59b005f89d.xml2020-01-16
otcsenna-8-6-brown-tablet-1.jpg2020-01-16
otcdb7f210c-d3cf-4b04-a645-081e04def54a.xml2019-01-17
otcsenna-8-6-tablet-brown-1.jpg2019-01-17