FREDS SALINE TWIN PACK LAXATIVE- sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema

FREDS SALINE TWIN PACK by

Drug Labeling and Warnings

FREDS SALINE TWIN PACK by is a Otc medication manufactured, distributed, or labeled by FRED'S, NATUREPLEX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Use

• relieves occasional constipation
• this product generally produces a 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.

Ask a doctor before use if you

• already used a laxative for more than 3 days
• have kidney disease, have heart problems, or are dehydrated
• are 55 years old or older
• are on a sodium-restricted diet
• have abdominal pain, nausea, or vomiting
• have a sudden change in bowel habits lasing 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 old and older: 1 bottle once daily
• Children 2 to under 12 years old: Use Pediatric Enema
• Children under 2 years: DO 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?

866-323-0107 or www.natureplex.com

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

NDC: 55315-301-01

fred's
Pharmacy

SALINE
enema
TWIN PACK

For Relief of
Occasional
Constipation

Ready-to-Use
Soft, Easy to use Bottle
Not Made with Natural
Rubber Latex

2
BOTTLES
4.5 FL OZ (133 mL) each

Compare To
Fleet®*

INGREDIENTS AND APPEARANCE

FREDS SALINE TWIN PACK   LAXATIVE
sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-301
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	7 g  in 133 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	19 g  in 133 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-301-01	2 in 1 CARTON	12/20/2019
1		133 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	12/20/2019

Labeler - FRED'S (005866116)

Establishment
Name	Address	ID/FEI	Business Operations
NATUREPLEX LLC		062808196	MANUFACTURE(55315-301)