SUNMARK SALINE SINGLE  LAXATIVE- sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema 
Strategic Sourcing Services 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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Sunmark® Saline Enema Single
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?

1-800-633-5463

Distributed By Strategic Sourcing Services LLC
6555 State Highway 161, Irving, TX 75039

PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton

sunmark®

COMPARE TO
FLEET® ENEMA SALINE
ACTIVE INGREDIENTS*

NDC 49348-186-20

complete &
ready-to-use
enema
Saline Laxative

For relief of
occasional constipation

Soft, flexible
Comfort tip

Pre-mixed

LATEX FREE

4.5 FL OZ
(133 ml)

PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton
SUNMARK SALINE SINGLE   LAXATIVE
sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-186
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:49348-186-201 in 1 CARTON03/06/2013
1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49348-186-142 in 1 CARTON03/06/2013
2133 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/06/2013
Labeler - Strategic Sourcing Services LLC (116956644)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(49348-186)

Revised: 7/2020
Document Id: 449d8174-1ca9-497e-a897-fd307482aceb
Set id: 06720229-7d58-499e-b7de-cb4bda5ae416
Version: 3
Effective Time: 20200730
 
Strategic Sourcing Services LLC