Laxative Pills

Manufacturer
Freds Inc
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:20:00

Label at a glance#

ProductLaxative Pills Maximum Strength
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement un 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 of age and older  take 2 tablets once or twice daily  children 6 to under 12 years of age  take 1 tablet once or twice daily  children under 6 years of age  ask a doctor

Storage and handling

each tablet contains: calcium 50 mg very low sodium store between 20-25ºC (68-77ºF)

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 un 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • are taking a prescription 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 of age and older take 2 tablets once or twice daily
 children 6 to under 12 years of age take 1 tablet once or twice daily
 children under 6 years of age ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 50 mg
  • very low sodium
  • store between 20-25ºC (68-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, ammonium hydroxide*, calcium carbonate*, calcium phosphate dihydrate*, calcium sulfate anhydrous*, carnauba wax, corn starch*, croscarmellose sodium, dicalcium phosphate*, FD&C blue #1, hypromellose*, iron oxide*, iron oxide black, iron oxide yellow*, isopropyl alcohol*, kaolin*, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil*, n-butyl alcohol*, polyethylene glycol, polyvinyl alcohol*, povidone*, propylene glycol*, shellac*, silicon dioxide, sodium lauryl sulfate*, stearic acid, sucrose, talc, titanium dioxide, white wax*

*contains one or more of these ingredients

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

Laxative Pills

Sennosides USP, 25 mg

Stimulant Laxative • Natural Senna Ingredient • For Gentle, Dependable Overnight Relief

Compare To The Active Ingredients in ex-lax® Maximum Strength†

TABLETS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

†This product is not manufactured or distributed by GlaxoSmithKline pic, distributor of Ex-Lax®.

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL ROAD,

MEMPHIS, TN 38118

www.fredsinc.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FRED"S Maximum Strength Laxative Pills
FRED"S Maximum Strength Laxative Pills

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55315-49255315-492-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

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
becc9550-2f0d-402a-9429-7485fa042594e6dad5f3-70db-49c3-8f5b-d4042bc72f2a2023-11-28WarningsExact identifier
spl id: becc9550-2f0d-402a-9429-7485fa042594
spl set id: e6dad5f3-70db-49c3-8f5b-d4042bc72f2a

Reported adverse events (FAERS/openFDA)#

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