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NDC 69626-0084-06 Relief 7; 19 g/133mL; g/133mL Details

Relief 7; 19 g/133mL; g/133mL

Relief is a RECTAL ENEMA in the HUMAN OTC DRUG category. It is labeled and distributed by Leosons Overseas Corp. The primary component is SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC.

Product Information

NDC	69626-0084
Product ID	69626-0084_b6ca079e-e502-099e-e053-2a95a90afff7
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	SODIUM PHOSPHATE, MONOBASIC and SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
Product Type	HUMAN OTC DRUG
Dosage Form	ENEMA
Route	RECTAL
Active Ingredient Strength	7; 19
Active Ingredient Units	g/133mL; g/133mL
Substance Name	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC
Labeler Name	Leosons Overseas Corp
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69626-0084-06 (69626008406)

Pricing Information	N/A
NDC Package Code	69626-0084-6
Billing NDC	69626008406
Package	1 BOTTLE, WITH APPLICATOR in 1 CARTON (69626-0084-6) / 133 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date	2015-02-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5b301d5b-1e2c-47ed-a05f-d6be0fdfc940 Details

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

Single daily dosage.
Do not use more unless directed by a doctor. See Warnings.
Do not use if taking another sodium phosphates product.

Adults and Children 12 years and over	1 Bottle
Children 2 to under 12 years	1/2 Bottle once daily
Children under 2 years	DO NOT USE

Other information

each 118 mL delivered dose contains: sodium 4.4 g
additional liquids by mouth are recommended while using this product
this product generally produces a bowel movement in 1-5 minutes
store between 15°- 30°C (59°- 86°F)
carton sealed for safety. Do not use if top or bottom flap of carton is torn or missing.
consult PHYSICIANS' DESK REFERENCE® for complete professional labeling.

Inactive ingredients

Benzalkonium chloride, disodium EDTA, purified water

Questions?

Call toll-free at +1-855-452-9500 or email [email protected]

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

Pre-Mixed
Latex Free

Lubricated Tip

1 Bottle 4.5 FL OZ (133mL)

INGREDIENTS AND APPEARANCE

RELIEF

sodium phosphate, monobasic and sodium phosphate, dibasic, heptahydrate enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69626-0084
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, MONOBASIC	19 g in 133 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	7 g in 133 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69626-0084-6	1 in 1 CARTON	02/09/2015
1		133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/09/2015

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