CITROMA- magnesium citrate liquid 
Carbia International

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.

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Lemon Magnesium Citrate
166.000/166AA rev 1-AB

Active ingredient (in each fl oz)

Magnesium citrate 1.745g

Purpose

Saline laxative

Uses

Warnings

for this product

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

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)

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

Directions

adults and children 12 years of age and over - 6.5 to 10 fl oz maximum 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 maximum 3 fl oz in 24 hours

children under 2 years of age - ask a doctor

other information

Inactive ingredients

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

Adverse Reaction

Distributed by Cariba International

P.O. Box 1208

Safety Harbor, Florida 34695

MADE IN USA WITH US AND FOREIGN COMPONENTS

Principal display panel

CARIBA

CARE

Magnesium

Citrate

SALINE LAXATIVE

ORAL SOLUTION

Lemon Flavor

Non-Pasteurized

Very Low Sodium

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

10 FL OZ (296 mL)

image description

CITROMA 
magnesium citrate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67860-166
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE1.745 g  in 29.6 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67860-166-38296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/18/2018
Labeler - Carbia International (049354067)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(67860-166)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(67860-166)

Revised: 5/2023
Document Id: e5a169db-82c8-4cd9-bda4-24b657d2e35c
Set id: e38824e3-ba27-4801-8089-e17b8bedf343
Version: 12
Effective Time: 20230522
 
Carbia International