HUMCO SENNA POWDER- senna powder powder
Humco Holding Group, 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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Humco Senna Powder USP

Drug Facts

Active Ingredient

Senna Powder

Purpose

Stimulant laxative

Use

For the temporary relief of occasional constipation. Bowel movement is generlly produced in 6 to 12 hours.

Warnings

Do not use 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 persits over a period of 2 weeks. Laxative product should not be used for a period of longer than 1 week unless directed by a doctor. Frequent and prolonged use may result in the dependednce on laxatives.

When using this product

Discontiniu use and consult a doctor if you have rectal bleeding or failure to hav a bowel movement after the use of a laxative. These symptoms 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 accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

Adults and children 12 yrs. of age and older: oral dose is 1/2 t 1 teaspoonful once or twice daily or as directed by a doctor.

Children 6 to under 12 yrs. of age: oral dose is 1/4 to 1/2 teaspoonful once or twice daily or as directed by a doctor.

Children under 6 yrs. of age: oral dosage is 1/4 to 1/2 teaspoonful once or twice daily or as dircted by a doctor.

Inactive Ingredient

Principal display panel

Label

image description

HUMCO SENNA POWDER
senna powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0395-2655
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	1000 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0395-2655-10	284 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017	11/14/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/25/1998	11/14/2017

Labeler - Humco Holding Group, Inc. (825672884)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc		825672884	manufacture(0395-2655) , analysis(0395-2655) , pack(0395-2655) , label(0395-2655)

Revised: 11/2017

Document Id: 5df327da-454d-76e4-e053-2a91aa0a977c

Set id: 373cddef-8865-4af3-aedb-50a786148bfd

Version: 2

Effective Time: 20171114

Humco Holding Group, Inc.