Rexall® Ready to use Enema 4pk LAXATIVE

Rexall® Ready to use Enema 4pk LAXATIVE

Drug Labeling and Warnings

Drug Details

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REXALL READY TO USE 4PK  LAXATIVE- sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema 
Dolgencorp, LLC

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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Rexall® Ready to use Enema 4pk
LAXATIVE

Drug Facts

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

Ask a doctor before use if you

  • have already used a laxative for more than 3 days
  • have kidney disease, have heart problems, or are dehydrated
  • are 55 years of age or older
  • are on a sodium-restricted diet
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasting more than 2 weeks

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.

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: 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 of age and older1 bottle once daily
Children 2 to under 12 years of ageUse Pediatric Enema
Children under 2 years of ageDO 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?

Visit us at: Rexall.com or call 1-866-4-REXALL

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

NDC: 55910-999-06

Since 1903
Rexall®

Ready-to-Use
Enema
Saline Laxative

Sodium Phosphates
Rectal Solution

NOT MADE WITH
NATURAL RUBBER LATEX

  • For relief of occasional
    constipation
  • Comfortable,
    lubricated tip
  • Easy, soft squeeze bottle

4
PACK

4 Bottles
4.5 FL OZ (133 mL) Each
TOTAL 18 FL OZ (532 mL)

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
REXALL READY TO USE 4PK   LAXATIVE
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55910-999
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 FORM7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 g  in 118 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: 55910-999-064 in 1 CARTON06/25/2018
1133 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33406/25/2018
Labeler - Dolgencorp, LLC (068331990)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(55910-999)

Revised: 6/2019
 
Dolgencorp, LLC


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