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  5. Label Information: Pro-enema Single Saline Laxative

FDA Label for Pro-enema Single Saline Laxative

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USE
    4. DOSAGE WARNING
    5. ASK A DOCTOR BEFORE USE IF YOU
    6. ASK A DOCTOR BEFORE USING ANY LAXATIVE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. SINGLE DAILY DOSAGE (PER 24 HOURS)
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 133 ML BOTTLE CARTON

Pro-enema Single Saline Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Propharma Medical Supplies. 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


Otc - Purpose



Active ingredients (in each 118mL delivered dose)Purpose
Dibasic Sodium Phosphate 7 gSaline laxative
Monobasic Sodium Phosphate 19 gSaline laxative

Use



Relieves occasional constipation


Dosage Warning



Using more than one enema in 24 hours can be harmful.

For rectal use only.


Ask A Doctor Before Use If You



  • already used a laxative for more than 1 week
  • have kidney disease
  • have heart problems
  • are dehydrated
  • are 55 years old or older
  • are on a sodium-restricted diet

Ask A Doctor Before Using Any Laxative If You Have



  • abdominal pain, nausea, or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

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

Stop Use And Ask A Doctor If



  • you have bleeding
  • the condtion worsens or does not improve within 7 days
  • 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:


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 older1 bottle once daily
Children 2 to under 12 years old1/2 bottle once daily
Children under 2 yearsDO NOT USE

Other Information



  • each 118 ml contains 4.4 g sodium
  • store at 15 to 30°C (59 to 86°F)
  • additional liquids by mouth are recommended while using this product
  • this product generally produces a bowel movement in 1 to 5 minutes
  • carton sealed for safety. Do not use if top or bottom flap of the 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 00000-000-00

*Compare To Fleet®

Ready-to-Use
Pro-Enema
Saline

Latex
Free

For relief of
occasional
constipation

1 Bottle
4.5 Fl Oz (133 mL)

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton - pro enema 01

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton - pro enema 01


* Please review the disclaimer below.