SENNA-TABS- senna 8.6mg tablet, film coated

Senna-Tabs by

Drug Labeling and Warnings

Senna-Tabs by is a Otc medication manufactured, distributed, or labeled by PHARMAMED USA 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)
• generally produces a bowel movement in 6-12 hours

Warnings

Do not use

• laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after the use of a laxative.

These 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 an overdose, get medical help or contact a Poison Control Center right away (1 800-222-1222).

Directions

• take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years and over	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years	½ tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

Other information

• each tablet contains: calcium 31 mg, sodium 2 mg, Very Low Sodium
• store at 20º -25ºC (68º-77ºF); excursions permitted between 15º -30º C (59º-86º F)

Inactive ingredients

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

Questions or comments?

(866) 562-2756 (Mon - Fri 8 AM to 4 PM EST)

Package Label Principal Display Panel

PHARMAMED

NDC: 84289-363-01

Manufactured in the USA

Natural Vegetable Laxative Ingredient

Senna

100 TABLETS

8.6 mg each

*Compare to the active ingredient of Senokot

INGREDIENTS AND APPEARANCE

SENNA-TABS 
senna 8.6mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84289-363(NDC:73057-363)
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TRIACETIN (UNII: XHX3C3X673)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TALC (UNII: 7SEV7J4R1U)

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: 84289-363-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/01/2024

Labeler - PHARMAMED USA INC (065607328)

Registrant - PHARBEST PHARMACEUTICALS, INC. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
PHARBEST PHARMACEUTICALS, INC.		557054835	repack(84289-363)