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Drug Facts
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
Freds Saline Twin Pack Enema
FDA Label NDC 55315-301
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fred's for the product Freds Saline Twin Pack (NDC 55315-301). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, use, warnings, dosage warning, ask a doctor before use if you, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 118mL delivered dose) | Purpose |
|---|---|
| Dibasic Sodium Phosphate 7 g | Saline laxative |
| Monobasic Sodium Phosphate 19 g | Saline laxative |
Use
- relieves occasional constipation
- this product generally produces a 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.
Ask A Doctor Before Use If You
- already used a laxative for more than 3 days
- have kidney disease, have heart problems, or are dehydrated
- are 55 years old or older
- are on a sodium-restricted diet
- have abdominal pain, nausea, or vomiting
- have a sudden change in bowel habits lasing 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.
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
Stop Use And Ask A Doctor If
- you have rectal bleeding
- you have no bowel movement within 30 minutes of enema use
- you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)
These symptoms may indicate a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
| Adults and children 12 years old and older | 1 bottle once daily |
| Children 2 to under 12 years old | Use Pediatric Enema |
| Children under 2 years | DO NOT USE |
Other Information
- each 118 ml contains 4.3 g sodium
- 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 - 133 Ml Bottle Carton
NDC 55315-301-01
fred's
Pharmacy
SALINE
enema
TWIN PACK
For Relief of
Occasional
Constipation
Ready-to-Use
Soft, Easy to use Bottle
Not Made with Natural
Rubber Latex
2
BOTTLES
4.5 FL OZ (133 mL) each
Compare To
Fleet®*
Principal Display Panel (133 mL Bottle Carton)
* Please review the disclaimer below.
