LAX-TIME- 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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195R Sennosides tablets USP 25 mg sugar coated off-white

Each Tablet contains:

CALCIUM SENNOSIDES 25 mg

INACTIVE INGREDIENTS: acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, 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.

195R Lax-Time (Sennosides) 25 mg

195R-timely-90s-label195 label

LAX-TIME 
sennosides tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-083
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 b25 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)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
RAW SUGAR (UNII: 8M707QY5GH)  
TALC (UNII: 7SEV7J4R1U)  
ACACIA (UNII: 5C5403N26O)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL083
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-083-0050000 in 1 CARTON; Type 0: Not a Combination Product08/30/2018
2NDC:49483-083-0995 in 1 BOTTLE; Type 0: Not a Combination Product12/31/2021
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(49483-083)

Revised: 2/2023
Document Id: f4b65706-1160-2b88-e053-2a95a90a0922
Set id: 74a627fc-00e5-eb78-e053-2991aa0abacc
Version: 3
Effective Time: 20230214
 
TIME CAP LABORATORIES, INC