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  5. Label Information: Reflief Saline Laxative Pediatric Ready To Use

FDA Label for Reflief Saline Laxative Pediatric Ready To Use

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USE
    4. WARNINGS
    5. DOSAGE WARNING
    6. DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. WHEN USING THIS PRODUCT
    10. OTC - STOP USE
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS (OR AS DIRECTED BY A DOCTOR)
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 67 ML BOTTLE CARTON

Reflief Saline Laxative Pediatric Ready To Use Product Label

The following document was submitted to the FDA by the labeler of this product Leosons International. 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:
Leosons
10 Maryland Avenue
Albany, New York 12205


Otc - Purpose



Active ingredients (in each 59 ml delivered dose)Purpose
Dibasic Sodium Phosphate 3.5gSaline laxative
Monobasic Sodium Phosphate 9.5gSaline 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.


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 are 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.


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 ageUse 1 bottle once daily
children under 2 years of ageDO NOT USE

Other Information



  • each 59 mL contains 2.2g 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?



Call toll-free at +1-855-452-9500 or email [email protected]


Principal Display Panel - 67 Ml Bottle Carton



NDC 69626-0085-7

RELIEF™
SALINE LAXATIVE

Pediatric
Ready-to-Use

ENEMA

For relief of
occasional
constipation

* Please review the disclaimer below.