FDA.reportPublic FDA data

MAXIMUM STRENGTH LAXATIVE

Manufacturer
CVS HEALTH | TIME CAP LABS,INC | TIME CAP LABORATORIES, INC.
Effective date
2025-02-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:55:16

Label at a glance#

ProductMAXIMUM STRENGTH LAXATIVE
Active ingredientSENNOSIDES
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Sennosides USP, 25 mg

OTC - PURPOSE SECTION

Purpose

Stimulant laxative

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

OTC - WHEN USING SECTION

When using this product do not use for a period longer than 1 week

OTC - STOP USE SECTION

Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

Directions

  • swallow tablet (s) with a glass of water.
  • swallow tablet (s) whole, do not crush, break or chew.

adults and children 12 years of age and older

2 tablets once or twice daily

children 6 to under 12 years of age

1 tablet once or twice daily

children under 6 years of age

ask a doctor

OTHER SAFETY INFORMATION

Other information

  • each tablet contains: calcium 40 mg, sodium 2 mg (VERY LOW SODIUM)
  • store between 20°-25°C (68°-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide.

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

195R- CVS 24ct IFC195R- CVS 24ct IFC

195R- CVS 90ct IFC195R- CVS 90ct IFC

195R- CVS 90ct label195R- CVS 90ct label

195R- CVS 250ct label195R- CVS 250ct label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251292sennosides 25 MG Oral TabletPSN3
251292sennosides, USP 25 MG Oral TabletSCD3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-195-092025-02-13C16284748780-12cef2736-95b5-d83d-e063-dadaa90ab31f195R-CVS MAXIMUM STRENGTH LAXATIVE
69842-195-242025-02-13C16284748780-12cef2736-95b5-d83d-e063-dadaa90ab31f195R-CVS MAXIMUM STRENGTH LAXATIVE
69842-195-252025-02-13C16284748780-12cef2736-95b5-d83d-e063-dadaa90ab31f195R-CVS MAXIMUM STRENGTH LAXATIVE
69842-195-092025-01-30C16284748780-12cef2736-95b5-d83d-e063-dadaa90ab31f195R-CVS MAXIMUM STRENGTH LAXATIVE
69842-195-242025-01-30C16284748780-12cef2736-95b5-d83d-e063-dadaa90ab31f195R-CVS MAXIMUM STRENGTH LAXATIVE
69842-195-252025-01-30C16284748780-12cef2736-95b5-d83d-e063-dadaa90ab31f195R-CVS MAXIMUM STRENGTH LAXATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-195-09MAXIMUM STRENGTH LAXATIVE90 in 1 BOTTLE, PLASTICTABLET, COATED903
69842-195-24MAXIMUM STRENGTH LAXATIVE24 in 1 BLISTER PACKTABLET, COATED243
69842-195-25MAXIMUM STRENGTH LAXATIVE250 in 1 BOTTLE, PLASTICTABLET, COATED2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-195MAXIMUM STRENGTH LAXATIVE (SENNOSIDES) TABLET, COATED [CVS HEALTH]3Current NDC, Legacy NDC, 3 package rows20250215_b05ee52f-4801-d4ca-e053-2995a90af348.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-195-09EA - Each69842-195c2aaa7db-9792-4f75-9f22-68aeab27d12912021-05-05

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-19569842-195-24, 69842-195-09, 69842-195-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
KAOLIN24H4NWX5COIACT
MALTODEXTRIN7CVR7L4A2DIACT
SENNOSIDES3FYP5M0IJXACTIB
CALCIUM SULFATE ANHYDROUSE934B3V59HIACT
CARNAUBA WAXR12CBM0EIZIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
SHELLAC46N107B71OIACT
ACACIA5C5403N26OIACT
IRON OXIDES1K09F3G675IACT

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
MAXIMUM STRENGTH LAXATIVESENNOSIDESCVS HEALTHb05ee52f-4801-d4ca-e053-2995a90af3482025-02-12WarningsExact identifier
ndc (package): 69842-195-09
ndc (package): 69842-195-24
ndc (package): 69842-195-25
ndc (product): 69842-195
ndc11 (package): 69842019509
ndc11 (package): 69842019524
ndc11 (package): 69842019525
spl id: 2dffd9ed-8b4b-a56b-e063-6394a90ae043
spl set id: b05ee52f-4801-d4ca-e053-2995a90af348

Reported adverse events (FAERS/openFDA)#

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