SENNA TABS- senna tablet, film coated

Senna Tabs by

Drug Labeling and Warnings

Senna Tabs by is a Otc medication manufactured, distributed, or labeled by Pharbest Pharmaceuticals, Inc., Pharbest Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Sennosides 8.6mg

Purpose

Laxative

Uses

• relieves occasional constipation (irregularity)
  
• this product generally produces a bowel movement in 6 to 12 hours
  

Warnings

Do not use

for more than one week unless directed by a doctor

Ask a doctor before use if you

• have abdominal pain, nausea, or vomiting
  
• are taking mineral oil
• noticed a sudden change in bowel habits that last over 2 weeks
  

Stop use and ask a doctor if

• you have no bowel movement within 12 hours
  
• you have rectal bleeding

These could 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

• do not exceed recommended dose

Age	Starting Dose	Maximum Dose
adults and children 12 years of age and older	2 tablets once a day preferably at bedtime; increase if needed, or as directed by a doctor	4 tablets twice a day, in the morning and at bedtime
children under 12 years	ask a doctor	ask a doctor

Other information

• Tamper Evident: Do not use if safety seal under cap is broken or missing
• each tablet contains: calcium 20 mg, potassium 70 mg
  
• store at room temperature 
  

Inactive ingredients:

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Questions?

Adverse drug event call: (866) 562-2756

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA TABS 
senna tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16103-363
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)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16103-363-08	100 in 1 BOTTLE, PLASTIC
2	NDC: 16103-363-11	1000 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/24/2007

Labeler - Pharbest Pharmaceuticals, Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc		557054835	manufacture, pack, label