CITROMA- magesium citrate liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838)
Available from:
TOPCO ASSOC, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Saline laxative for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours 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.
Authorization status:
OTC monograph not final
Authorization number:
36800-164-38

CITROMA- magesium citrate liquid

TOPCO ASSOC, 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.

----------

Top Care 164.000 1664AA rev 2

Active Ingredient

Magnesium citrate 1.745g per fl oz

Purpos e

Saline laxative

us e

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 or sodium restricted diet

abdorominal pain, nausea, or vomiting

noticed a sudden change in bowel habits tat 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 help professional before use.

Keep out of reach of children.

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

other informaiton

Store at temperatures betweem 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 in 24 hours

children under 2 years of age - ask a doctor

other information

each fl oz contains: magnesium 295 mg

each fl oz contains: sodium 1 mg

Inactive ingredients

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

Adverse Reaction

DIST. BY TOPCO ASSOC LLC

7711 GROSS POINT RD, SKOKIE, IL 60077 TOPCO AAR507

QUESTIONS? 1-888-423-0139

topcare@topco.com

164.000/164AA rev 2

principal display panel

TOP CARE

CHERRY FLAVOR

Magnesium

Citrate Oral

Solution

SALINE LAXATIVE

QUALITY

GUARANTEED

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

FROM NECKRING

10 FL OZ (296 mL)

CITROMA

magesium citrate liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -16 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MAGNESIUM CITRATE (UNII: RHO26 O1T9 V) (MAGNESIUM CATION -

UNII:T6 V3LHY8 38 )

MAGNESIUM

CITRATE

1.745 g

in 29 .6 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

wa ter (UNII: 0 59 QF0 KO0 R)

TOPCO ASSOC, LLC

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:36 8 0 0 -16 4-

29 6 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/18 /20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

0 2/18 /20 18

Labeler -

T OPCO ASSOC, LLC (006935977)

Registrant -

Vi-Jon (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

79 0 752542

ma nufa c ture (36 8 0 0 -16 4)

Revised: 6/2020

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