RELIEF- sodium phosphate, monobasic and sodium phosphate, dibasic, heptahydrate enema 
Leosons Overseas Corp

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 Saline Laxative 4.5 fl oz

Drug Facts

Drug Facts

Active ingredients & Purpose

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

Use

for relief of occasional constipation

Warnings

For rectal use only

Dosage Warning:

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

Ask a doctor before using this product if you

  • are on a sodium-restricted diet
  • have kidney disease
  • are 65 or older and under a doctor's care for any medical condition

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

Stop use and ask a doctor if you have

  • rectal bleeding
  • no bowel movement within 30 minutes of enema use
  • symptoms of dehydration (feeling thirsty, dizziness, vomiting, urinating less often than normal)

These symptoms may indicate a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and Children 12 years and over1 Bottle
Children 2 to under 12 years1/2 Bottle once daily
Children under 2 yearsDO NOT USE

Other information

Inactive ingredients

Benzalkonium chloride, disodium EDTA, purified water

Questions?

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 - 133 mL Bottle Carton

RELIEF

SALINE LAXATIVE

Ready-to-Use
ENEMA

For relief of
occasional
constipation

Lubricated Tip
1 Bottle 4.5 FL OZ (133mL)

Principal Display Panel - 133 mL Bottle Carton

RELIEF 
sodium phosphate, monobasic and sodium phosphate, dibasic, heptahydrate enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69626-0084
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC19 g  in 133 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE7 g  in 133 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:69626-0084-61 in 1 CARTON02/09/2015
1133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/09/2015
Labeler - Leosons Overseas Corp (148605470)

Revised: 12/2020
Document Id: b6ca079e-e502-099e-e053-2a95a90afff7
Set id: 5b301d5b-1e2c-47ed-a05f-d6be0fdfc940
Version: 3
Effective Time: 20201218
 
Leosons Overseas Corp