Laxative

Manufacturer
Topco Associates, LLC | LNK International, Inc.
Effective date
2023-10-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:24:15

Label at a glance#

ProductLaxative Maximum Strength
Active ingredientSENNOSIDES
Label structure9 sections

Indications and uses

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

Dosage and administration

swallow tablet(s) with a glass of water swallow tablet(s) whole; do not crush, break, or chew adults and children 12 years and over 2 tablets once or twice daily children 6 to under 12 years 1 tablet once or twice daily children under 6 years ask a doctor

Storage and handling

each tablet contains: calcium 40 mg, magnesium 5 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides USP, 25 mg

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

When using this product,

OTC - WHEN USING SECTION

do not use for a period longer than 1 week.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow tablet(s) with a glass of water
  • swallow tablet(s) whole; do not crush, break, or chew
adults and children 12 years and over2 tablets once or twice daily
children 6 to under 12 years1 tablet once or twice daily
children under 6 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 40 mg, magnesium 5 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide black, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

+TopCare®
health

NDC 36800-305-08

COMPARE TO EX•LAX®
MAXIMUM STRENGTH
ACTIVE INGREDIENT†

MAXIMUM STRENGTH
Laxative
SENNOSIDES USP, 25 mg • STIMULANT LAXATIVE

• Senna Ingredient
• Gentle, Dependable Constipation Relief

24 COATED TABLETS

actual
size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

†This product is not manufactured or distributed
by GSK Consumer Healthcare S.A., owner of the
registered trademark ex•lax® Maximum Strength.

✓QUALITY GUARANTEED
50844
ORG041934808

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0221
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.com

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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
36800-30536800-305-08

Ingredients#

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

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

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
ce11001d-fbd3-4cd9-aabf-00bae620b2c560ea0f82-d24d-4390-aabd-b56a74df42ac2023-10-11WarningsExact identifier
spl id: ce11001d-fbd3-4cd9-aabf-00bae620b2c5
spl set id: 60ea0f82-d24d-4390-aabd-b56a74df42ac

Reported adverse events (FAERS/openFDA)#

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