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NDC 00121-4967-40 Senna Syrup 8.8 mg/5mL Details
Senna Syrup 8.8 mg/5mL
Senna Syrup is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is SENNOSIDES.
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: 00121-4967-40Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Senna
Product Information
| NDC | 00121-4967 |
|---|---|
| Product ID | 0121-4967_e79e9c91-c923-6c35-e053-2a95a90aa851 |
| Associated GPIs | 46200060201220 |
| GCN Sequence Number | 002922 |
| GCN Sequence Number Description | sennosides SYRUP 8.8MG/5ML ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 08660 |
| HICL Sequence Number | 001289 |
| HICL Sequence Number Description | SENNOSIDES |
| Brand/Generic | Generic |
| Proprietary Name | Senna Syrup |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sennosides |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 8.8 |
| Active Ingredient Units | mg/5mL |
| Substance Name | SENNOSIDES |
| Labeler Name | Pharmaceutical Associates, 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 00121-4967-40 (00121496740)
| NDC Package Code | 0121-4967-40 |
|---|---|
| Billing NDC | 00121496740 |
| Package | 4 TRAY in 1 CASE (0121-4967-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4967-05) |
| Marketing Start Date | 2022-03-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Do not use
- laxative products for longer than 1 week unless directed by a doctor
Ask a doctor or pharmacist before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden changed in bowel movement that continues over a period of 2 weeks
Stop use and ask a doctor if
you have rectal bleeding or failure to have a bowel movemebt after use of laxative. They may indicate a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
- shake well before use
- Do not exceed recommended dose
| Age | Starting Dose | Maximum dosage |
| Adults and children 12 years and older | 2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor | 3 teaspoons in the morning and 3 teaspoons at bedtime |
| Under 12 years of age | ask a doctor | ask a doctor |
Other information
- store at room temperature 20° to 25°C (68° to 77°F).
- a brown, natural flavored syrup supplied in the following oral dosage form:
NDC 0121-4967-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-4967-40: Case contains 40 unit dose cups of 5 mL (0121-4967-05) packaged in 4 trays of 10 unit dose cups each.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| SENNA SYRUP
sennosides liquid |
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| Labeler - Pharmaceutical Associates, Inc. (044940096) |
| Registrant - Pharmaceutical Associates, Inc. (097630693) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Pharmaceutical Associates, Inc. | 097630693 | manufacture(0121-4967) , label(0121-4967) | |