Label: HUMCO SENNA LEAVES- senna leaves extract
- NDC Code(s): 0395-2649-01, 0395-2649-94
- Packager: Humco Holding Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 13, 2018
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
For the temporary relief of occasional constipation. Bowel movement is generlly produced in 6 to 12 hours.Close
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.Close
- 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.Close
- 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.Close
- Keep out of reach of children
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.Close
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.Close
- Inactive Ingredient
- Principal display panel
- INGREDIENTS AND APPEARANCE
HUMCO SENNA LEAVES
senna leaves extract
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-2649 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 1000 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-2649-94 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/13/2017 2 NDC:0395-2649-01 454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/25/1998 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Humco Holding Group, Inc. (825672884) Establishment Name Address ID/FEI Business Operations Humco Holding Group, Inc 825672884 manufacture(0395-2649) , analysis(0395-2649) , pack(0395-2649) , label(0395-2649)