SENNA by MAJOR PHARMACEUTICALS / TIME CAP LABORATORIES, INC MAJOR-191R

SENNA by

Drug Labeling and Warnings

SENNA by is a Otc medication manufactured, distributed, or labeled by MAJOR PHARMACEUTICALS, TIME CAP LABORATORIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SENNA- senna tablet, coated 
MAJOR PHARMACEUTICALS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

MAJOR-191R

Each tablet contains Sennisides 8.6 mg

Inactive Ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Directions:

Take preferably at bedtime or as directed by a doctor; if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable.

Adults and children 12 years and over - 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 - ask a doctor

Relieves occasional constipation (irregularity;generally causes bowel movement in 6-12 hours

WARNINGS: Do not use laxative products for longer than 1 week unless directed by a doctor

PURPOSE: LAXATIVE

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

SENNA 
senna tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6434
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)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
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	9mm
Flavor		Imprint Code	TCL080
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6434-80	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/09/2015	12/27/2019
2	NDC: 0904-6434-59	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/09/2015	12/27/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/09/2015	12/27/2019

Labeler - MAJOR PHARMACEUTICALS (191427277)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC		037052099	manufacture(0904-6434)

Revised: 12/2019

Document Id: 98e0129e-cc61-5b63-e053-2995a90a26a6

34390-5

Set id: 8dae128b-9c04-4f05-95dc-fb7d83a16398

Version: 3

Effective Time: 20191204

 

MAJOR PHARMACEUTICALS