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NDC 00363-0005-39 Saline Laxative 7; 19 g/118mL; g/118mL Details
Saline Laxative 7; 19 g/118mL; g/118mL
Saline Laxative is a RECTAL ENEMA in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM.
Product Information
| NDC | 00363-0005 |
|---|---|
| Product ID | 0363-0005_7c2042b5-460a-4f8d-83f4-ee20a5770f23 |
| Associated GPIs | 46200060200515 |
| GCN Sequence Number | 039784 |
| GCN Sequence Number Description | sennosides TAB CHEW 15 MG ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 12162 |
| HICL Sequence Number | 001289 |
| HICL Sequence Number Description | SENNOSIDES |
| Brand/Generic | Generic |
| Proprietary Name | Saline Laxative |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | 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 | Walgreen Company |
| 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 00363-0005-39 (00363000539)
| NDC Package Code | 0363-0005-39 |
|---|---|
| Billing NDC | 00363000539 |
| Package | 6 BOTTLE in 1 BOX (0363-0005-39) / 133 mL in 1 BOTTLE |
| Marketing Start Date | 2016-03-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL fb260df0-7bda-4299-84a5-44c8f9447798 Details
SPL UNCLASSIFIED SECTION
Use
Warnings
Ask a doctor before use if the child
- has already used a laxative for more than 3 days
- has kidney disease, have heart problems, or is dehydrated
- is on a sodium-restricted diet
- has abdominal pain, nausea, or vomiting
- has a sudden change in bowel habits lasting more than 2 weeks
Ask a doctor or pharmacist before use if the child is 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.
| children 2 to under 12 years of age | Use 1 bottle once daily |
| children under 2 years of age | DO NOT USE |
Other information
PRINCIPAL DISPLAY PANEL - 67 mL Bottle Box
INGREDIENTS AND APPEARANCE
| SALINE LAXATIVE
sodium phosphate enema |
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| Labeler - Walgreen Company (008965063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Natureplex LLC | 062808196 | MANUFACTURE(0363-0005) | |
Revised: 3/2021
Document Id: 7c2042b5-460a-4f8d-83f4-ee20a5770f23
Set id: fb260df0-7bda-4299-84a5-44c8f9447798
Version: 9
Effective Time: 20210325