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NDC 11673-0164-38 citroma 1.745 g/29.6mL Details

citroma 1.745 g/29.6mL

citroma is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Target. The primary component is MAGNESIUM CITRATE.

Product Information

NDC	11673-0164
Product ID	11673-164_446ae1ff-df53-49c8-aa83-3fd4f7247a64
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	citroma
Proprietary Name Suffix	n/a
Non-Proprietary Name	Magnesium Citrate
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	1.745
Active Ingredient Units	g/29.6mL
Substance Name	MAGNESIUM CITRATE
Labeler Name	Target
Pharmaceutical Class	Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 11673-0164-38 (11673016438)

Pricing Information	N/A
NDC Package Code	11673-164-38
Billing NDC	11673016438
Package	296 mL in 1 BOTTLE, PLASTIC (11673-164-38)
Marketing Start Date	2018-02-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 71bd2790-c180-4a10-89d4-bc1b5a6fba8d Details

Active Ingredient

Magnesium citrate 1.745g per fl oz

Purpose

Saline laxative

use

for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours

Warnings

for this product

Ask A Doctor

before use if you have

kidney disease
a magnesium restricted diet
abdorominal pain, nausea, or vomiting
noticed a sudden change in bowel habits that persists over a period of 2 weeks
already used a laxative for a period longer than 1 week

Ask a doctor or pharmacist

before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use

and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

if pregnant or breast-feeding

ask health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away

Store at temperatures between 46° and 86°F (8° and 30° C)

Directions

drink a full glass (8 ounces) of liquid with each dose
may be taken as a single daily dose or in divided doses

adults and children 12 years of age and over - 6.5 to 10 fl oz in 24 hours

children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours

children 2 to under 6 years of age - 2 to 3 fl oz maximum in 24 hours

children under 2 years of age - ask a doctor

other information

each fl oz contains: magnesium 290 mg
each fl oz contains: sodium 1 mg

Inactive ingredients

benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

Adverse Reaction

Dist. by Target Corp., Mpls., MN 55403

Made in the U.S.A. with U.S. and foreign components

TM m@2018 Target Brands, Inc.

principal display panel

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

magnesium citrae saline laxative

oral solution

alcohol content 0.0205% (from flavoring)

up & up

CHERRY FLAVOR

10 FL OZ (296 mL)

INGREDIENTS AND APPEARANCE

CITROMA

magnesium citrate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11673-164
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CITRATE	1.745 g in 29.6 mL

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SUCRALOSE (UNII: 96K6UQ3ZD4)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11673-164-38	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/18/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/18/2018

Labeler - Target (006961700)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(11673-164)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(11673-164)

Revised: 4/2022

Document Id: 446ae1ff-df53-49c8-aa83-3fd4f7247a64

Set id: 71bd2790-c180-4a10-89d4-bc1b5a6fba8d

Version: 10

Effective Time: 20220428