SENNA LAXATIVE- sennosides tablet

SENNA LAXATIVE by

Drug Labeling and Warnings

SENNA LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

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
• have noticed a sudden change in bowel habits that lasts over two 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 8 tablets in 24 hours

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

Other information

• each tablet contains: calcium 20 mg
• store at room temperature 15-30C (59-86F)

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG.

HOW SUPPLIED

Product: 71335-0026

NDC: 71335-0026-5 30 TABLET in a BOTTLE

NDC: 71335-0026-3 120 TABLET in a BOTTLE

NDC: 71335-0026-6 90 TABLET in a BOTTLE

NDC: 71335-0026-1 100 TABLET in a BOTTLE

NDC: 71335-0026-4 56 TABLET in a BOTTLE

NDC: 71335-0026-2 60 TABLET in a BOTTLE

Sennosides 8.6mg Tablet

INGREDIENTS AND APPEARANCE

SENNA LAXATIVE 
sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-0026(NDC: 49348-165)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	brown (light brown)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	1122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-0026-5	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016
2	NDC: 71335-0026-3	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016
3	NDC: 71335-0026-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016
4	NDC: 71335-0026-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016
5	NDC: 71335-0026-4	56 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016
6	NDC: 71335-0026-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/01/2016

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0026) , RELABEL(71335-0026)