DR SIMI REGULAR STRENGTH SENNOSIDES 8.6MG- sennosides 8.6mg tablet, coated

Dr Simi Regular Strength Sennosides 8.6mg by

Drug Labeling and Warnings

Dr Simi Regular Strength Sennosides 8.6mg by is a Otc medication manufactured, distributed, or labeled by Farmacias De Similares TX LLC, Contract Pharmacal Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

- relieves occasional constipation (irregularity)

- generally produces a bowel movement in 6-12 hours

Warnings

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 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.

Keep out of reach of children.

In case of overdose

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

Directions

- take preferably at bedtime or as directed by a doctor.

Age	Starting Dosage	Maximum Dosage
adults and children 12 years of age 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	1/2 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 20 mg
- Store in a dry place at 15° - 30C (59° - 86°F)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, talc.

Questions or comments?

855-280-1079

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark Senokot®.

Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com
www.drsimi.com

PRINCIPAL DISPLAY PANEL

Dr. Simi

NDC: 85786-501-50

Compare to Senokot® Regular Strength active ingredient*

Regular Strength

Sennosides 8.6 mg
Laxative

Standardized Senna Concentrate Natural Vegetable Laxative Ingredient

50 tablets

INGREDIENTS AND APPEARANCE

DR SIMI REGULAR STRENGTH SENNOSIDES 8.6MG 
sennosides 8.6mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-501
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)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
TALC (UNII: 7SEV7J4R1U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	W2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-501-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	01/01/2026

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corp		057795122	pack(85786-501) , label(85786-501)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corp		079157508	manufacture(85786-501)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corp		968334974	manufacture(85786-501)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corp		968335112	manufacture(85786-501)