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NDC 00067-8141-01 EX-LAX 15 mg/1 Details

EX-LAX 15 mg/1

EX-LAX is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is SENNOSIDES.

MedlinePlus Drug Summary

Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Related Packages: 00067-8141-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Senna

Product Information

NDC	00067-8141
Product ID	0067-8141_7a0ee04e-9da2-40c8-81c6-29dd56c0ccf2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	EX-LAX
Proprietary Name Suffix	REGULAR STRENGTH STIMULANT LAXATIVE
Non-Proprietary Name	SENNOSIDES
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	15
Active Ingredient Units	mg/1
Substance Name	SENNOSIDES
Labeler Name	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00067-8141-01 (00067814101)

Pricing Information	N/A
NDC Package Code	0067-8141-01
Billing NDC	00067814101
Package	1 BLISTER PACK in 1 CARTON (0067-8141-01) / 8 TABLET in 1 BLISTER PACK
Marketing Start Date	2017-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 62544c2f-6e30-4cec-ae63-233715ef0699 Details

Active ingredient (in each tablet)

Sennosides 15 mg

Purpose

Stimulant laxative

Uses

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

Warnings

Do not use

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

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.

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.

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 information

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

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

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

Questions ?

call 1-855-221-5432

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

Principal Display Panel

NDC 0067-8141-02

ex•lax®

SENNOSIDES, 15 mg

REGULAR STRENGTH

STIMULANT LAXATIVE

RELIEF GUARANTEED

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 GSK, attention Consumer Affairs, for full refund.

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

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

13143

exlax regular strength tablet 30 count carton

INGREDIENTS AND APPEARANCE

EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE

sennosides pill

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-0003
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	15 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
ALGINIC ACID (UNII: 8C3Z4148WZ)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (Beige)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	ex;lax;1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0067-0003-08	1 in 1 CARTON	01/01/2012	11/30/2019
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0067-0003-30	2 in 1 CARTON	01/01/2012	11/30/2019
2		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/01/2012	11/30/2019

EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE

sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-8141
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	15 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN (Tan)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ex;lax;1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0067-8141-01	1 in 1 CARTON	07/01/2017
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0067-8141-02	2 in 1 CARTON	07/01/2017
2		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	07/01/2017

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 12/2020

Document Id: 7a0ee04e-9da2-40c8-81c6-29dd56c0ccf2

Set id: 62544c2f-6e30-4cec-ae63-233715ef0699

Version: 6

Effective Time: 20201203

Search by Drug Name or NDC

NDC 00067-8141-01 EX-LAX 15 mg/1 Details

EX-LAX 15 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00067-8141-01 (00067814101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 62544c2f-6e30-4cec-ae63-233715ef0699 Details

Active ingredient (in each tablet)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients (0067-0003)

Inactive Ingredients (0067-8141)

Questions ?

Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

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