190R Sennosides tablets USP 15 mg sugar coated off-white

190R Sennosides tablets USP 15 mg sugar coated off-white

Drug Labeling and Warnings

Drug Details

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SENNOSIDES- sennosides tablet, sugar coated 
TIME CAP LABORATORIES, INC

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.

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190R Sennosides tablets USP 15 mg sugar coated off-white

Each Tablet contains:

Sennosides 15 mg

INACTIVE INGREDIENTS:acacia, calcium sulfate anhydrous, carnauba wax, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, FD&C Red#40, FD&C Yellow#6, iron oxide, iron oxide black, iron oxide yellow, Kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol(PEG 400), povidone, Shellac, Sugar, Talc, Titanium dioxide

stool softner, laxative

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 (not to 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 6 to under 12 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day

Children under 2 years - Ask a doctor

Uses:

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

WARNINGS:

Do not use this product

If you are presently taking mineral oil, unless directed by a doctor

Laxative products for longer than 1 week unless directed by a doctor




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

190R LABEL

SENNOSIDES 
sennosides tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49483-079
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B15 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
RAW SUGAR (UNII: 8M707QY5GH)  
TALC (UNII: 7SEV7J4R1U)  
ACACIA (UNII: 5C5403N26O)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL079
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49483-079-0050000 in 1 CARTON; Type 0: Not a Combination Product08/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/30/2018
Labeler - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099manufacture(49483-079)

Revised: 8/2018
 
TIME CAP LABORATORIES, INC


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