HUMCO SENNA LEAVES- senna leaves extract 
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 Leaves

Drug Facts

Active Ingredient

Senna Leaves

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. Frequent or prolonged use may result in the dependence on laxatives.

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.

When using this product

Discontinie 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 to 3 teaspoonful of tea (prepared as indicated below) once or twice daily or as directed by a doctor.

not recommended for Children under 12 yrs. of age. Consult a doctor before use.

Prepare a tea by steeping 1 ounce of rinsed Senna Leaves in one pint boiling water; let stand 1 hour. Then strain. Press out all the liquid and discard leaves.

Inactive Ingredient

none

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HUMCO SENNA LEAVES 
senna leaves extract
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-2649
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B1000 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-2649-94113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/201709/30/2019
2NDC:0395-2649-01454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/201709/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/25/199809/30/2019
Labeler - Humco Holding Group, Inc. (825672884)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIBusiness Operations
Humco Holding Group, Inc825672884manufacture(0395-2649) , analysis(0395-2649) , pack(0395-2649) , label(0395-2649)

Revised: 6/2020
 
Humco Holding Group, Inc.