Label: CITROMA MAGNESIUM CITRATE- citroma magnesium citrate liquid
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- NDC Code(s): 0869-0686-38
- Packager: Vi-Jon
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 12, 2018
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- Official Label (Printer Friendly)
- active ingredient
- purpose
- Use
for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours
Close - Warnings
- ask a doctor before use if you have
- kidney disease
- a magnesium or potassium-restricted diet
- abdominal 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.
Close - 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.
Close - If pregnant or breast-feeding
- Keep out of reach of children.
- Directions
- drink a full glass (8 ounces) of liquid with each dose
- may be taken as a single daily dose or in dividied 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 - ask a doctor
discard unused product within 24 hours of opening bottle
Close - Other information
- each fl oz contains: magnesium 290 mg
- each fl oz contains: potassium 80 mg
- store at temperatures between 46° and 86° F (8° and 30° C)
- inactive ingredients
- adverse readtion
- Principal Display Panel
NDC 0869-0686-38
swan
VERY LOW SODIUM
Citroma
MAGNESIUM CITRATE
Lemony
- Saline Laxative
- Oral Solution
Do not use if tamper evident twist-off cap is missing, broken or separated from neckring
10 FL OZ (296 mL)
Close
- principal display panel
DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING
mountain
falls
low
sodium
lemon
flavor
magnesium
citrate
saline laxative
oral solution
10 FL OZ (296 mL)
Close
- INGREDIENTS AND APPEARANCE
CITROMA MAGNESIUM CITRATE
citroma magnesium citrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0686 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Magnesium citrate (UNII: RHO26O1T9V) (magnesium cation - UNII:T6V3LHY838) Magnesium citrate 1.745 g in 29.6 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LEMON OIL (UNII: I9GRO824LL) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) water (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0869-0686-38 296 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 06/19/1979 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 06/19/1979 Labeler - Vi-Jon (790752542) Registrant - Vi-Jon (790752542) CloseEstablishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(0869-0686)