SENNA-S- senna and docusate sodium tablets, 8.6 mg and 50 mg tablet

SENNA-S by

Drug Labeling and Warnings

SENNA-S by is a Otc medication manufactured, distributed, or labeled by Advance Pharmaceutical Inc., Time Cap Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Senna Tablets- 8.6 mg 

Docusate Sodium- 50 mg

PURPOSE

Senna Tablets- 8.6 mg ..........Laxative

Docusate Sodium- 50 mg........Stool softner

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6-12 hours

Warnings

Do not use

• if you are now taking mineral oil, unless directed by a doctor
• 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 lasts over 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take preferably at bedtime or as directed by a doctor

• adults and children 12 years of age or older - starting dosage: 2 tablets once a day, maximum dosage: 4 tablets twice a day
• children 6 to under 12 years - starting dosage: 1 tablet once a day, maximum dosage: 2 tablets twice a day
• children 2 to under 6 years - starting dosage: 1/2 tablet once a day, maximum dosage: 1 tablet twice a day
• children under 2 years - starting dosage: ask a doctor, maximum dosage: ask a doctor

Other information

• each tablet contains: calcium 21 mg
• each tablet contains: sodium 3 mg VERY LOW SODIUM
• store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
• read all product information before using
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

carnuba wax, croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, D&C Yellow # 10, FD&C Yellow # 6, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, stearic acid, titanium dioxide

Questions or comments?

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PRINCIPAL DISPLAY PANEL

NDC- 17714-124-10

Senna and Docusate Sodium Tablets, 8.6 mg and 50 mg

INGREDIENTS AND APPEARANCE

SENNA-S 
senna and docusate sodium tablets, 8.6 mg and 50 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17714-124
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL;081
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17714-124-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/01/2017

Labeler - Advance Pharmaceutical Inc. (078301063)

Registrant - Advance Pharmaceutical Inc. (078301063)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Laboratories, Inc.		037052099	manufacture(17714-124)