Senna Plus Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

SENNA PLUS- senna plus tablet 
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

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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Senna Plus Drug Facts

Active ingredient

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

Purpose

Laxative & Stool Softener

Uses

For the short term relief of constipation. Produces bowel movement in 6 to 12 hours.

Warnings

Do not use ° for longer than one week ° when abdominal pain, nausea or vomiting are present.

Ask a doctor or pharmacist before use if you have noticed a sudden change in bowel habits that lasts over a period of two weeks.

Stop use and ask a doctor if ° you have rectal bleeding ° you fail to have a bowel movement after use of this product, this may indicate a serious condition.

If pregnant or breast-feeding, ask a health care 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 ° if you do not have a comfortable bowel movement by the second day, increase dose by one table (do not exceed the maximum dosage) or decrease dose until you are comfortable.

Adults & children over 12 years: 2 tablets once a day (maximum dosage, 4 tablets twice a day)

Children 6 to under 12 years: 1 tablet once a day (maximum dosage, 2 tablets twice a day)

Children 2 to under 6 years: 1.2 tablet once a day (maximum dosage, 1 tablet twice a day)

Children under 2 years: do not use

Other Information

Store at room temperature, USP.

Inactive ingredients

Croscarmellose Sodium, Dicalcium Phosphate, FD&C Yellow No. 5, FD&C Yellow No. 6, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Starch, Stearic Acid and Titanium Dioxide.

Distributed by: Plus Pharma

Commack, NY 11725

Repackaged by: Rebel Distributors Corp

Thousand Oaks, CA 91320

Image of Label

SENNA PLUS 
senna plus tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49999-711(NDC: 21695-722)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	CPC490
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49999-711-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2012	06/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/15/2012	06/30/2018

Labeler - Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)

Establishment
Name	Address	ID/FEI	Business Operations
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC		831276758	REPACK(49999-711)

Revised: 6/2019

Document Id: 63224dfa-dfd0-4a1f-86d3-e7bd076b8ecc

34390-5

Set id: 6a891ab7-77b9-4a62-bddb-7f303bbbdd23

Version: 3574

Effective Time: 20190604

 

Lake Erie Medical & Surgi