Premier Value 44-348 Delisted

Premier Value 44-348 Delisted
SPL v13
SPL
SPL Set ID 49ee4e99-5655-47e6-8bc9-e8cb8f60b9d1
Route
ORAL
Published
Effective Date 2025-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (25 mg)
Inactive Ingredients
Acacia Calcium Carbonate Carnauba Wax Starch, Corn Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Ferrosoferric Oxide Magnesium Stearate Methylparaben Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Propylene Glycol Propylparaben Shellac Silicon Dioxide Sodium Benzoate Sodium Lauryl Sulfate Sucrose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;348 Shape: round Color: blue Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2003-01-02 Until 2026-03-31

Description

Sennosides USP, 25 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Sennosides USP, 25 mg

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



Do Not Use

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

Other Information
  • 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

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?

1-800-426-9391

Principal Display Panel

Premier 

Value®

*COMPARE TO THE ACTIVE INGREDIENT IN

ex•lax® MAXIMUM STRENGTH

Maximum Strength

Laxative


Sennosides USP, 25 mg

STIMULANT LAXATIVE

24 Tablets

actual

size

Gentle, Dependable

Constipation Relief

PV

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

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.

50844                   REV0419B34808

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

If for any reason you are

not satisfied with this product,

please return it to the store

where purchased

for a full refund.

Premier Value 44-348

When Using This Product,

do not use for a period longer than 1 week.

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Sennosides USP, 25 mg

Ask A Doctor Before Use If You Have

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

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


Structured Label Content

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

Stimulant laxative

Directions
  • 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



Do Not Use (Do not use)

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

Other Information (Other information)
  • 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 ingredients)

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? (Questions or comments?)

1-800-426-9391

Principal Display Panel

Premier 

Value®

*COMPARE TO THE ACTIVE INGREDIENT IN

ex•lax® MAXIMUM STRENGTH

Maximum Strength

Laxative


Sennosides USP, 25 mg

STIMULANT LAXATIVE

24 Tablets

actual

size

Gentle, Dependable

Constipation Relief

PV

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

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.

50844                   REV0419B34808

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

If for any reason you are

not satisfied with this product,

please return it to the store

where purchased

for a full refund.

Premier Value 44-348

When Using This Product, (When using this product,)

do not use for a period longer than 1 week.

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Sennosides USP, 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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 (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.


Advanced Ingredient Data


Raw Label Data

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