Label: HIS ULC MINT BLUE- calcium carbonate tablet, chewable
-
Contains inactivated NDC Code(s)
NDC Code(s): 49789-060-01 - Packager: SAMSUNG PHARM IND. CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 3, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
1. The following people must consult a doctor, dentist or pharmacist before administering the drug.
(1) Patients with kidney disorders
(2) Patients taking other drugs2. Patients must immediately stop adminstration of the drug and consult a doctor, dentist or pharmacist if the following symptoms are observed. Carry these instructions when visiting.
(1) If symptoms of constipation or diarrhea occur while administering this drug
(2) When no improvement is detected after 2 weeks of administration3. Other precautions when administering this drug
(1) Follow the given instructions and dosages
(2) When administering to children, it must be administered under the supervision of a parent or guardian4. Storage directions
(1) Store in places out of the reach of children
(2) Keep away from direct sunlight and store sealed in cool places with low humidity.
(3) Do not store in different containers in order to prevent misuse and preserve quality (Only store in container if it has been specifically labelled and is not open to misuse) - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HIS ULC MINT BLUE
calcium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49789-060 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) Calcium carbonate 350 mg in 492 mg Inactive Ingredients Ingredient Name Strength magnesium hydroxide (UNII: NBZ3QY004S) Aspartame (UNII: Z0H242BBR1) Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor MINT Imprint Code SSPN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49789-060-01 492 mg in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 12/01/2012 Labeler - SAMSUNG PHARM IND. CO., LTD. (687744425) Registrant - SAMSUNG PHARM IND. CO., LTD. (687744425) Establishment Name Address ID/FEI Business Operations SAMSUNG PHARM IND. CO., LTD. 687744425 manufacture(49789-060)
