FDA Label for Cvs Pharmacy
View Indications, Usage & Precautions
Cvs Pharmacy Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
Otc - Purpose
| Active ingredients (in each 59 mL delivered dose) | Purpose |
|---|---|
| Dibasic Sodium Phosphate 3.5g | Saline laxative |
| Monobasic Sodium Phosphate 9.5g | Saline laxative |
Use
- relieves occasional constipation
- this product generally produces bowel movement in 1 to 5 minutes
Warnings
For rectal use only.
Dosage Warning
Using more than one enema in 24 hours can be harmful.
Otc - Ask Doctor
Ask a doctor or pharmacist before using if the child
- 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
Otc - Ask Doctor/Pharmacist
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.
Otc - When Using
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
Otc - Stop Use
Stop use and ask a doctor if the child
- has rectal bleeding
- has no bowel movement within 30 minutes of enema use
- has symptoms of dehydration (thirstiness, dizzyness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed get medical help or contact a Poison Control Center right away: 800-222-1222.
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 11 years | 1 bottle once daily |
| children under 2 years | ask a doctor |
Other Information
- each 59 mL contains: sodium 2.2g
- store at 15 to 30°C (59 to 86°F)
- additional liquids by mouth are recommended while using this product
- Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
Inactive Ingredients
benzalkonium chloride, disodium EDTA, purified water
Questions Or Comments?
866-323-0107 or www.natureplex.com
Principal Display Panel - 66 Ml Bottle Carton
CVS
Health™
Compare to the active
ingredients in Fleet®
Pedia-Lax Enema*
NDC 59779-969-40
Children's
Ready-to-Use
Enema
SALINE LAXATIVE
- Pre-mixed
- For relief of occasional
constipation - Lubricated tip
AGES
2-11
2.25 FL OZ (66 mL)
* Please review the disclaimer below.