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NDC 49483-0079-01 SENNOSIDES 15 mg/1 Details
SENNOSIDES 15 mg/1
SENNOSIDES is a ORAL TABLET, SUGAR COATED in the HUMAN OTC DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, INC. The primary component is 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: 49483-0079-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Senna
Product Information
| NDC | 49483-0079 |
|---|---|
| Product ID | 49483-079_97f141d0-789f-8d30-e053-2a95a90ac315 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | SENNOSIDES |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | SENNOSIDES |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, SUGAR COATED |
| Route | ORAL |
| Active Ingredient Strength | 15 |
| Active Ingredient Units | mg/1 |
| Substance Name | 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 49483-0079-01 (49483007901)
| NDC Package Code | 49483-079-01 |
|---|---|
| Billing NDC | 49483007901 |
| Package | 100 TABLET, SUGAR COATED in 1 BOTTLE, PLASTIC (49483-079-01) |
| Marketing Start Date | 2018-08-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7498f5fa-1739-bb6e-e053-2a91aa0a5404 Details
SPL UNCLASSIFIED SECTION
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
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 (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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| SENNOSIDES
sennosides tablet, sugar coated |
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| Labeler - TIME CAP LABORATORIES, INC (037052099) |
| Registrant - TIME CAP LABORATORIES, INC. (037052099) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| TIME CAP LABORATORIES, INC. | 037052099 | manufacture(49483-079) | |