FDA Label for Saline Laxative
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USE
- DOSAGE WARNING
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS (OR AS DIRECTED BY A DOCTOR)
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 67 ML BOTTLE BOX
Saline Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
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
Dosage Warning
Using more than one enema in 24 hours can be harmful.
For rectal use only.
Do Not Use
- on children under 2 years of age
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
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.
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, dizziness, 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 under 12 years of age | Use 1 bottle once daily |
children under 2 years of age | DO NOT USE |
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?
1-866-323-0107
Principal Display Panel - 67 Ml Bottle Box
Walgreens
Compare to Fleet®
Pedia-Lax® Enema
active ingredients††
NDC 0363-0005-40
READY-TO-USE
Pediatric
Enema
SALINE LAXATIVE
SALINE LAXATIVE
PRE-MIXED
- For relief of
occasional
constipation - Comfortable,
lubricated tip - Not made
with natural
rubber latex
NOT ACTUAL SIZE
2.25 FL OZ (67 mL)
* Please review the disclaimer below.