Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 62544c2f-6e30-4cec-ae63-233715ef0699
Route
ORAL
Published
Effective Date 2016-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (15 mg)
Inactive Ingredients
Acacia Alginic Acid Carnauba Wax Silicon Dioxide Anhydrous Dibasic Calcium Phosphate Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Magnesium Stearate Microcrystalline Cellulose Potassium Hydroxide Propylene Glycol Shellac Sodium Benzoate Sodium Lauryl Sulfate Stearic Acid Sucrose Talc Titanium Dioxide Calcium Carbonate Starch, Corn Methylparaben Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Propylparaben

Identifiers & Packaging

Pill Appearance
Imprint: ex;lax;1 Shape: round Color: white Color: brown Size: 11 mm Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-07-01 Until 2019-11-30

Description

Sennosides 15 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Sennosides 15 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 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

Do Not Use

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

Questions ?

call 1-855-221-5432

Other Information
  • each tablet contains: calcium 45 mg, magnesium 5mg
  • store at controlled room temperature 20-25°C (68-77°F)
Principal Display Panel

NDC 0067-0003-30

Regular Strength

ex•lax®

SENNOSIDES, USP, 15 mg

STIMULANT LAXATIVE

RELIEF GUARANTEED EVERY TIME

GENTLE OVERNIGHT RELIEF YOU CAN TRUST

The Ex•Lax® Guarantee: When taken as directed, Ex•Lax® is guaranteed to work gently and effectively overnight or your money back. Return product to Novartis, attention Consumer Affairs, for full refund.

Tamper Evident Feature: Ex•Lax® Pills are sealed in blister packets. Use only if the individual seal is unbroken.

Trademarks are owned by or licensed to GSK group of companies

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

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 right away.

Inactive Ingredients (0067 8141)

acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

Inactive Ingredients (0067 0003)

acacia, alginic acid, carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, iron oxides, magnesium stearate, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide

Active Ingredient (in Each Tablet)

Sennosides 15 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 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

Do Not Use (Do not use)

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

Questions ?

call 1-855-221-5432

Other Information (Other information)
  • each tablet contains: calcium 45 mg, magnesium 5mg
  • store at controlled room temperature 20-25°C (68-77°F)
Principal Display Panel

NDC 0067-0003-30

Regular Strength

ex•lax®

SENNOSIDES, USP, 15 mg

STIMULANT LAXATIVE

RELIEF GUARANTEED EVERY TIME

GENTLE OVERNIGHT RELIEF YOU CAN TRUST

The Ex•Lax® Guarantee: When taken as directed, Ex•Lax® is guaranteed to work gently and effectively overnight or your money back. Return product to Novartis, attention Consumer Affairs, for full refund.

Tamper Evident Feature: Ex•Lax® Pills are sealed in blister packets. Use only if the individual seal is unbroken.

Trademarks are owned by or licensed to GSK group of companies

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

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 right away.

Inactive Ingredients (0067 8141) (Inactive Ingredients (0067-8141))

acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

Inactive Ingredients (0067 0003) (Inactive ingredients (0067-0003))

acacia, alginic acid, carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, iron oxides, magnesium stearate, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide

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

Sennosides 15 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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