VALUMEDS NATURAL LAXATIVE

Set ID
5e6f4436-efcb-46f1-a87b-ba2ff43292f0
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:41:27

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 bowel movement in 6-12 hours

Warnings

Warnings

Directions And Dosage

Directions

Age Starting Dosage Maximum Dosage adults and children 12 years of age or 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 tablet 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 24 mg and sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, maltodextrin, purified water, sodium lauryl sulphate, stearic acid

Questions or comments?

Call 1-888-333-9792

PRINCIPAL DISPLAY PANEL - 8.6 mg Tablet Bottle

VALUMEDS *COMPARE TO THE ACTIVE INGREDIENT IN SENOKOT ® Natural Laxative Sennosides USP, 8.6 mg Laxative Gentle, Overnight Relief Natural Vegetable Laxative Ingredient Actual Size 100 TABLETS

Products

NDC Codes

Ingredients

NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MINERAL OILT5L8T28FGPIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MALTODEXTRIN7CVR7L4A2DIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
SENNOSIDES3FYP5M0IJXACTIB

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

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 bowel movement in 6-12 hours

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Age Starting Dosage Maximum Dosage adults and children 12 years of age or 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 tablet 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 24 mg and sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, hypromellose, liquid paraffin, magnesium stearate, microcrystalline cellulose, maltodextrin, purified water, sodium lauryl sulphate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-333-9792

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779

PRINCIPAL DISPLAY PANEL - 8.6 mg Tablet Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUMEDS *COMPARE TO THE ACTIVE INGREDIENT IN SENOKOT ® Natural Laxative Sennosides USP, 8.6 mg Laxative Gentle, Overnight Relief Natural Vegetable Laxative Ingredient Actual Size 100 TABLETS

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
29019

Legacy File Index

FolderFileDate
otc28da10e5-c30e-cf4a-e063-6394a90ab94e.xml2024-12-10
otc0bef4471-e36a-83e6-e063-6294a90a6a5d.xml2023-12-08
otcee514b10-d1f0-6df0-e053-2995a90accdb.xml2022-11-26
otcd21cbfda-17df-b17c-e053-2995a90a3399.xml2021-12-02
otcb60bc54e-a81f-122b-e053-2995a90a588d.xml2020-12-10
otc8f769dbd-3109-66a6-e053-2a95a90a1911.xml2019-08-08
otcVM SennaTablets8.6mg100ct451-01.jpg2019-08-08