SALINE LAXATIVE- saline laxative enema 
Major Pharmaceuticals

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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MAJOR® SALINE ENEMA
LAXATIVE

Drug Facts

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

Use

Warnings

Dosage warning

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

For rectal use only.

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

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

(800) 616-2471

Distributed by:
MAJOR® PHARMACEUTICALS
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

MAJOR®

NDC 0904-6320-78

Compare to the
active ingredients of
Fleet® Saline Enema*

Ready-to-Use
Enema
Saline Laxative

For relief of occasional
constipation

Not made with natural
rubber latex

4.5 FL OZ (133 mL)

1 Bottle

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
SALINE LAXATIVE 
saline laxative enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6320
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM7 g  in 133 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 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:0904-6320-78133 mL in 1 BOTTLE; Type 0: Not a Combination Product07/11/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/11/2013
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
NATUREPLEX LLC062808196MANUFACTURE(0904-6320)

Revised: 3/2021
Document Id: c4fb146c-fbdd-460e-8d33-d8f36fb39077
Set id: b3758ffe-1bac-4df6-9714-5e33e9d28d90
Version: 7
Effective Time: 20210323
 
Major Pharmaceuticals