SENNA- sennosides tablet, film coated
Ideal Protein of America 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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1122 - Ideal Protein

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

Distributed by Ideal Protein of America Inc.

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

Natura

Senna

Stimulant Laxative

100 tablets

NDC64418-1122-1

1122

SENNA
sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64418-1122
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Ideal Protein of America Inc. (013868390)

Revised: 4/2019

Document Id: 85931a38-2c4e-7249-e053-2a91aa0a103b

Set id: 73692953-eb20-497e-b15d-08ca86e262a0

Version: 5

Effective Time: 20190402

Ideal Protein of America Inc.