REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE- sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema 
Leosons International

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Relief Pediatric Enema (NaturePlex)

Drug Facts

Drug Facts

Active ingredients & Purpose

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

Uses

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

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

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

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.

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)

children 2 to under 12 years of ageUse 1 bottle once daily
children under 2 years of ageDO NOT USE

Other information

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

Call toll-free at +1-855-452-9500 or email info@Leosonsintl.com

Distributed by:


Leosons
10 Maryland Avenue
Albany, New York 12205

PRINCIPAL DISPLAY PANEL

NDC 69626-0085-7

RELIEF
SALINE LAXATIVE

Pediatric
Ready-to-Use

ENEMA

For relief of occasional constipation

Ages 2-11

Lubricated Tip
2.25 FL OZ (67 mL)

PRINCIPAL DISPLAY PANEL - 67 mL Bottle Carton

REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE 
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69626-0085
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM3.5 g  in 59 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM9.5 g  in 59 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69626-0085-71 in 1 CARTON10/01/2019
167 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/01/2019
Labeler - Leosons International (148605470)

Revised: 12/2022
Document Id: f0ffc0e9-bf91-a842-e053-2a95a90aa2f8
Set id: 90e7c2b4-35e1-4a27-afea-9257c480e190
Version: 2
Effective Time: 20221229
 
Leosons International