Search by Drug Name or NDC

NDC 49483-0081-10 SENNA TIME S 50; 8.6 mg/1; min/1 Details

SENNA TIME S 50; 8.6 mg/1; min/1

SENNA TIME S is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, INC. The primary component is DOCUSATE SODIUM; SENNOSIDES A AND B.

MedlinePlus Drug Summary

Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Related Packages: 49483-0081-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Senna

Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.

Related Packages: 49483-0081-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	49483-0081
Product ID	49483-081_d42e00f7-ef36-9efc-e053-2995a90a94fe
Associated GPIs	46991002770320
GCN Sequence Number	048044
GCN Sequence Number Description	sennosides/docusate sodium TABLET 8.6MG-50MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	13483
HICL Sequence Number	021772
HICL Sequence Number Description	SENNOSIDES/DOCUSATE SODIUM
Brand/Generic	Generic
Proprietary Name	SENNA TIME S
Proprietary Name Suffix	n/a
Non-Proprietary Name	DOCUSATE SODIUM-SENNOSIDES
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	50; 8.6
Active Ingredient Units	mg/1; min/1
Substance Name	DOCUSATE SODIUM; SENNOSIDES A AND B
Labeler Name	TIME CAP LABORATORIES, INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49483-0081-10 (49483008110)

Pricing Information
NDC Package Code	49483-081-10
Billing NDC	49483008110
Package	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-081-10)
Marketing Start Date	2018-12-14
NDC Exclude Flag	N
Price Per Unit	0.02987
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	SENNA-TIME S TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL dc491692-8d3a-4ccd-a17d-4c630f122595 Details

DRUG FACTS

SPL UNCLASSIFIED SECTION

Active ingredients (in each tablet)

Docustate sodium 50 mg

Sennosides 8.6 mg

SPL UNCLASSIFIED SECTION

Purposes

Stool softener

Stimulant laxative

SPL UNCLASSIFIED SECTION

Uses

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

SPL UNCLASSIFIED SECTION

Warnings

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have

stomach pain
nausea
vomiting
a sudden change in bowel movements that persists over 2 weeks

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative.

These could be signs of a serious condition

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding, ask a health professional before use.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

age	starting dosage	maximum dosage
adults and children 12 years of age and older	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	½ tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

SPL UNCLASSIFIED SECTION

Other information

each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

SPL UNCLASSIFIED SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow#10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

SPL UNCLASSIFIED SECTION

Questions or comments?

Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA TIME S

docusate sodium-sennosides tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49483-081
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 min

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL081
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49483-081-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2018
2	NDC:49483-081-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/14/2018
3	NDC:49483-081-00	100000 in 1 CARTON; Type 0: Not a Combination Product	12/14/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/14/2012

Labeler - TIME CAP LABORATORIES, INC (037052099)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
TIME CAP LABORATORIES, INC.		037052099	manufacture(49483-081)

Revised: 12/2021

Document Id: d42e00f7-ef36-9efc-e053-2995a90a94fe

Set id: dc491692-8d3a-4ccd-a17d-4c630f122595

Version: 4

Effective Time: 20211227

Search by Drug Name or NDC

NDC 49483-0081-10 SENNA TIME S 50; 8.6 mg/1; min/1 Details

SENNA TIME S 50; 8.6 mg/1; min/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49483-0081-10 (49483008110)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dc491692-8d3a-4ccd-a17d-4c630f122595 Details

DRUG FACTS

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Is Pepcid Safe To Take With Metronidazole?

Can You Take A Z-Pak If You Have A Penicillin Allergy?