Sennosides by Marlex Pharmaceuticals Inc SENNOSIDES tablet

Sennosides by

Drug Labeling and Warnings

Sennosides by is a Otc medication manufactured, distributed, or labeled by Marlex Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SENNOSIDES 8.6mg Tablet

Marlex Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

Warnings

Do not use

• laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

• stomach Pain
  
• Nausea
  
• Vomiting
  
• noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate 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

• take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years of age and older	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years of age	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years of age	1/2 tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

Other information

• Each tablet contains: Calcium 4mg, Sodium 3mg
  
• Store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15° to 30°C (59°-86°F).

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid

*Compare to Senokot®

Product color may vary slightly due to nature of ingredients.

*Marlex Pharmaceuticals, Inc. is not affiliated with the owner of the registered trademark Senokot®.

PRINCIPAL DISPLAY PANEL

NDC: 10135-0314-01
Sennosides
8.6 mg
100 TABLETS

INGREDIENTS AND APPEARANCE

SENNOSIDES 
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-314
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	BROWN (light brown to gray)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	S5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-314-01	1 in 1 CARTON	10/01/2018
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	10/01/2018

Labeler - Marlex Pharmaceuticals Inc (782540215)