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NDC 41250-0111-35 Meijer Enema 7; 19 g/118mL; g/118mL Details

Meijer Enema 7; 19 g/118mL; g/118mL

Meijer Enema is a RECTAL ENEMA in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution Inc. The primary component is SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM.

Product Information

NDC	41250-0111
Product ID	41250-111_b11cce22-3ca0-4d5d-8844-7fd1b42c1ce6
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	Meijer Enema
Proprietary Name Suffix	n/a
Non-Proprietary Name	Saline Laxative
Product Type	HUMAN OTC DRUG
Dosage Form	ENEMA
Route	RECTAL
Active Ingredient Strength	7; 19
Active Ingredient Units	g/118mL; g/118mL
Substance Name	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Labeler Name	Meijer Distribution Inc
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 41250-0111-35 (41250011135)

Pricing Information	N/A
NDC Package Code	41250-111-35
Billing NDC	41250011135
Package	1 BOTTLE in 1 CARTON (41250-111-35) / 133 mL in 1 BOTTLE
Marketing Start Date	2013-05-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2c82d239-261e-4e3d-8a90-caecb527bed3 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each 118 mL 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 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 older	1 bottle once daily
Children 2 to under 12 years of age	Use Pediatric Enema
Children under 2 years of age	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

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

meijer®

NDC 41250-111-37

Compare to Fleet® Enema Saline

active ingredients*

READY-TO-USE

enema

SALINE LAXATIVE

FOR RELIEF OF

OCCASIONAL

CONSTIPATION

SOFT, FLEXIBLE

COMFORT TIP

NOT MADE

WITH NATURAL

RUBBER LATEX

6 Bottles

4.5 Fl Oz (133 mL) each

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

INGREDIENTS AND APPEARANCE

MEIJER ENEMA

saline laxative enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-111
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	7 g in 118 mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	19 g in 118 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:41250-111-35	1 in 1 CARTON	05/10/2013
1		133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:41250-111-36	2 in 1 CARTON	05/10/2013
2		133 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:41250-111-37	6 in 1 CARTON	01/30/2020
3		133 mL in 1 BOTTLE; 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	05/10/2013

Labeler - Meijer Distribution Inc (006959555)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(41250-111)

Revised: 1/2020

Document Id: b11cce22-3ca0-4d5d-8844-7fd1b42c1ce6

Set id: 2c82d239-261e-4e3d-8a90-caecb527bed3

Version: 5

Effective Time: 20200131

Search by Drug Name or NDC

NDC 41250-0111-35 Meijer Enema 7; 19 g/118mL; g/118mL Details

Meijer Enema 7; 19 g/118mL; g/118mL

Product Information

Package

Package Images

NDC 41250-0111-35 (41250011135)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2c82d239-261e-4e3d-8a90-caecb527bed3 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Use

Warnings

Do not use

Ask a doctor before use if you

When using this product

Stop use and ask a doctor if

Directions (or as directed by a doctor)

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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