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NDC 30142-0005-35 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 Kroger Company. The primary component is SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM.
Product Information
| NDC | 30142-0005 |
|---|---|
| Product ID | 30142-005_b7aec228-5205-45a3-a794-d761edcc8ba5 |
| Associated GPIs | |
| 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 | 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 | Kroger 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 30142-0005-35 (30142000535)
| NDC Package Code | 30142-005-35 |
|---|---|
| Billing NDC | 30142000535 |
| Package | 2 BOTTLE in 1 BOX (30142-005-35) / 133 mL in 1 BOTTLE |
| Marketing Start Date | 2012-08-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d7560c7f-9366-4e09-ac24-7097f24f0746 Details
Active ingredient
Warnings
For rectal use only
Ask a doctor before use if you have
- •
- a sodium-restricted diet
- •
- abdominal pain, nausea or vomiting
- •
- kidney disease, heart problems, or are dehydrated
- •
- noticed a sudden change in bowel habits that lasts over 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
Directions
Do not use more unless directed by a doctor. See Warnings.
|
adults & children 12 years and over |
one bottle once daily |
|
children 2 to under 12 years |
1/2 bottle once daily Discard unused portion |
|
children under 2 years |
do not use |
CAUTION:
Remove green protective shield before inserting. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.
Positioning:
Left-side position: lie on left side with knee bent and arms at rest.
Knee-chest position: kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.
Administering enema:
- •
- with steady pressure, gently insert enema with tip pointing toward navel.
- •
- squeeze bottle until recommended dose is expelled (it is not necessary to empty unit completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing).
- •
- remove tip from rectum
- •
- stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
- •
- maintain position until urge to evacuate is strong (usually 1 to 5 minutes)
- •
- if no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
Other Information
PRINCIPAL DISPLAY PANEL - 2 Bottle Carton
COMPARE TO the active ingredients of
FLEET® ENEMA SALINE *See side panel
NDC 30142-005-35
TWIN
PACK
Kroger®
OUR PHARMACIST RECOMMENDED
READY-TO-USE
Enema
SALINE LAXATIVE
Soft, Flexible Tip
For Relief of Occasional
Constipation
- -
- Lubricated Tip for
Comfort Application - -
- Pre-Mixed
- -
- Not Made with
Natural Rubber
Latex
TAMPER EVIDENT
SAFETY SEALED
BOTTLES
FAST
RELIEF
2 BOTTLES
4.5 FL OZ (133 ml) EACH
TOTAL 9 FL OZ (266 mL)
INGREDIENTS AND APPEARANCE
| SALINE LAXATIVE
sodium phosphate enema |
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| Labeler - Kroger Company (006999528) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Natureplex LLC | 062808196 | MANUFACTURE(30142-005) | |