Search by Drug Name or NDC
NDC 36800-0002-36 topcare enema 7; 19 g/118mL; g/118mL Details
topcare enema 7; 19 g/118mL; g/118mL
topcare enema is a RECTAL ENEMA in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM.
Product Information
| NDC | 36800-0002 |
|---|---|
| Product ID | 36800-002_b7dd72f7-51ad-466a-90f4-deabf2c0a22c |
| Associated GPIs | 46109902105100 |
| 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 | topcare enema |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dibasic sodium phosphate, Monobasic sodium phosphate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | ENEMA |
| Route | RECTAL |
| Active Ingredient Strength | 7; 19 |
| Active Ingredient Units | g/118mL; g/118mL |
| Substance Name | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0002-36 (36800000236)
| NDC Package Code | 36800-002-36 |
|---|---|
| Billing NDC | 36800000236 |
| Package | 2 BOTTLE in 1 CARTON (36800-002-36) / 133 mL in 1 BOTTLE |
| Marketing Start Date | 2009-11-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4dfe410b-9248-4549-8bc4-3d3c35e2569d Details
SPL UNCLASSIFIED SECTION
Use
Warnings
For rectal use only.
Ask a doctor before use if you
- already used a laxative for more than 1 week
- have kidney disease
- have heart problems
- are dehydrated
- are 55 years old or older
- are on a sodium-restricted diet
Ask a doctor before using any laxative if you have
- abdominal pain, nausea, or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
When using this product
- do not use more than directed. Serious side effects may occur from excess dosage
- do not use for more than 3 days
Stop use and ask a doctor if
- you have bleeding
- condition worsens or does not improve within 7 days
- you have no bowel movement within 30 minutes of enema use
- you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)
These symptoms may indicate a serious condition.
Directions
Single daily dosage (per 24 hours)
Do not use if taking another sodium phosphate product.
Do not use more unless directed by a doctor. See Warnings.
| Adults and children 12 years old and older | 1 bottle once daily |
| Children 2 to under 12 years old | Use Pediatric Enema |
| Children under 2 years | DO NOT USE |
Other information
PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| TOPCARE ENEMA
dibasic sodium phosphate, monobasic sodium phosphate enema |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Labeler - Topco Associates LLC (006935977) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Natureplex LLC | 062808196 | MANUFACTURE(36800-002) | |
Revised: 1/2019
Document Id: b7dd72f7-51ad-466a-90f4-deabf2c0a22c
Set id: 4dfe410b-9248-4549-8bc4-3d3c35e2569d
Version: 5
Effective Time: 20190118