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NDC 57896-0758-16 GeriCare Sorbitol Solution 70 mg/100mL Details
GeriCare Sorbitol Solution 70 mg/100mL
GeriCare Sorbitol Solution is a RECTAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by GERI-CARE PHARMACEUTICALS, CORP. The primary component is SORBITOL.
Product Information
| NDC | 57896-0758 |
|---|---|
| Product ID | 57896-758_413c3c8f-57c6-4c2a-8589-87340ebb96d3 |
| Associated GPIs | 46600070002070 |
| GCN Sequence Number | 008612 |
| GCN Sequence Number Description | sorbitol solution SOLUTION 70 % MISCELL |
| HIC3 | U6N |
| HIC3 Description | VEHICLES |
| GCN | 45550 |
| HICL Sequence Number | 003836 |
| HICL Sequence Number Description | SORBITOL SOLUTION |
| Brand/Generic | Generic |
| Proprietary Name | GeriCare Sorbitol Solution |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sorbitol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | RECTAL |
| Active Ingredient Strength | 70 |
| Active Ingredient Units | mg/100mL |
| Substance Name | SORBITOL |
| Labeler Name | GERI-CARE PHARMACEUTICALS, CORP |
| 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 57896-0758-16 (57896075816)
| NDC Package Code | 57896-758-16 |
|---|---|
| Billing NDC | 57896075816 |
| Package | 473 mL in 1 BOTTLE (57896-758-16) |
| Marketing Start Date | 2020-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b4dd7a41-380e-d94b-e053-2a95a90ac34a Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
For rectal use only
Do not use
- when abdominal pain, nausea, or vomiting are present
- for more than one week unless directed by a doctor
Ask a doctor before use if
- are taking mineral oil
- have noticed a sudden change in bowel habits that lasts over 2 weeks
Stop use and aska doctor if you have a rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions Do not exceed recommended dose
| AGE | DOSE |
| Adults and children 12 years and over | For rectal use only. Enema dosage is 120 mL of a 25 to 30% w/v solution (1 part of this product with 2.3 parts water) in a single daily dose as needed, or as directed by your doctor. |
| Children under 12 years of age | Ask a doctor |
INGREDIENTS AND APPEARANCE
| GERICARE SORBITOL SOLUTION
sorbitol liquid |
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| Labeler - GERI-CARE PHARMACEUTICALS, CORP (611196254) |
Revised: 12/2020
Document Id: 413c3c8f-57c6-4c2a-8589-87340ebb96d3
Set id: b4dd7a41-380e-d94b-e053-2a95a90ac34a
Version: 3
Effective Time: 20201229