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NDC 67234-0020-03 NATUREPLEX 7; 19 g/133mL; g/133mL Details
NATUREPLEX 7; 19 g/133mL; g/133mL
NATUREPLEX is a RECTAL ENEMA in the HUMAN OTC DRUG category. It is labeled and distributed by Natureplex, LLC. The primary component is SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM.
Product Information
| NDC | 67234-0020 |
|---|---|
| Product ID | 67234-020_ef59dd61-3db3-4254-bd64-f8d199b7da48 |
| Associated GPIs | 46109902105100 |
| GCN Sequence Number | 003029 |
| GCN Sequence Number Description | sodium phosphate,mono-dibasic ENEMA 19G-7G/118 RECTAL |
| HIC3 | Q3S |
| HIC3 Description | LAXATIVES, LOCAL/RECTAL |
| GCN | 66559 |
| HICL Sequence Number | 001330 |
| HICL Sequence Number Description | SODIUM PHOSPHATE,MONOBASIC/SODIUM PHOSPHATE,DIBASIC |
| Brand/Generic | Brand |
| Proprietary Name | NATUREPLEX |
| Proprietary Name Suffix | Enema |
| Non-Proprietary Name | (saline) |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | ENEMA |
| Route | RECTAL |
| Active Ingredient Strength | 7; 19 |
| Active Ingredient Units | g/133mL; g/133mL |
| Substance Name | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM |
| Labeler Name | Natureplex, LLC |
| 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 67234-0020-03 (67234002003)
| NDC Package Code | 67234-020-03 |
|---|---|
| Billing NDC | 67234002003 |
| Package | 3 BOTTLE, WITH APPLICATOR in 1 CARTON (67234-020-03) / 133 mL in 1 BOTTLE, WITH APPLICATOR |
| Marketing Start Date | 2010-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0bd6d0a8-33e5-40be-a6c6-33fea92b11dd Details
SPL UNCLASSIFIED SECTION
Use
Warnings
For rectal use only.
Ask a doctor before use if you
- have already used a laxative for more than 3 days
- have kidney disease, have heart problems, or are dehydrated
- are 55 years of age or older
- have abdominal pain, nausea, or vomiting
- have a sudden change in bowel habits lasting more than 2 weeks
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
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, without asking a doctor
Directions (or as directed by a doctor)
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 of age and older | 1 bottle once daily |
| Children 2 to under 12 years of age | Use Pediatric Enema |
| Children under 2 years of age | DO NOT USE |
Other information
PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| NATUREPLEX
ENEMA
(saline) enema |
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| Labeler - Natureplex, LLC (062808196) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Natureplex, LLC | 062808196 | manufacture(67234-020) | |
Revised: 5/2018
Document Id: ef59dd61-3db3-4254-bd64-f8d199b7da48
Set id: 0bd6d0a8-33e5-40be-a6c6-33fea92b11dd
Version: 13
Effective Time: 20180524