SENNA- sennosides tablet, film coated

Senna by

Drug Labeling and Warnings

Senna by is a Otc medication manufactured, distributed, or labeled by Ideal Protein of America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

(in each tablet)

Sennosides 8.6 mg

Purpose

Stimulant laxative

Use

• Helps to relieve occasional constipation (irregularity)
• Bowel movements usually occur within 6-12 hours.

Warnings

Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a physician.

Consult a physician before use if you have noticed a sudden change in bowel habits that persist over a period of 2 weeks.

When using this product

do not use for a period longer than 1 week.

Stop use and consult a physician if you have rectal bleeding or fail 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

• Adults and children 12 years of age and older: 2-4 tablets once daily at bedtime, or as directed by a physician.
• Children under 12 years of age: consult a physician.

Other Information

• Each tablet contains: Calcium 20 mg
• Do not use if safety seal is broken
• After opening, store at room temperature away from humidity.
• Side effects may occur. You may report side effects to the FDA at 1-800-FDA-1088 (Toll Free).

Inactive Ingredients

Croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol.

Questions or comments?

1-866-314-4447 (Mon-Fri 8:30-4:30 EST)
www.idealprotein.com

SPL UNCLASSIFIED SECTION

Distributed by Ideal Protein of America Inc.

3135 SR 580 Suite #5, Safety Harbor, FL 34695

PRINCIPAL DISPLAY PANEL

Natura

Senna

Stimulant Laxative

100 tablets

NDC64418-1122-1

INGREDIENTS AND APPEARANCE

SENNA 
sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64418-1122
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	1122;1122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64418-1122-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2014	05/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/19/2014	05/31/2020

Labeler - Ideal Protein of America Inc. (013868390)