HIS ULC MINT BLUE- calcium carbonate tablet, chewable 
SAMSUNG PHARM IND. CO., LTD.

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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ACTIVE INGREDIENT

Active ingredient: Calcium carbonate 350mg

INACTIVE INGREDIENT

Inactive ingredients:
Magnesium hydroxide, L-menthol, Aspartame, Sugar, Povidone, Lactose Hydrate, Spirulina color, Mint flavor, Calcium carboxymethylcellulose, Magnesium stearate

PURPOSE

Effective for: Relieves:Heartburn, Sour stomach, Acid indigestion, Upset stomach associated with these symptoms

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 drugs

2. 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 administration

3. 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 guardian

4. 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

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

adult :take 2 tablets, 4/3 tablets for kids 11 to 14, 1 tablet for kids 8 to 10, 2/3 tablet for kids 5 to 7, 1/2 tablet for kids to 3 to 4, 3 times a day. Taken between meals or at bedtime
Taking a melt in your mouth and chew.

DOSAGE AND ADMINISTRATION

adult :take 2 tablets, 4/3 tablets for kids 11 to 14, 1 tablet for kids 8 to 10, 2/3 tablet for kids 5 to 7, 1/2 tablet for kids to 3 to 4, 3 times a day. Taken between meals or at bedtime
Taking a melt in your mouth and chew.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

HIS ULC MINT BLUE 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49789-060
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) Calcium carbonate350 mg  in 492 mg
Inactive Ingredients
Ingredient NameStrength
magnesium hydroxide (UNII: NBZ3QY004S)  
Aspartame (UNII: Z0H242BBR1)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorMINTImprint Code SSPN
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49789-060-01492 mg in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33112/01/2012
Labeler - SAMSUNG PHARM IND. CO., LTD. (687744425)
Registrant - SAMSUNG PHARM IND. CO., LTD. (687744425)
Establishment
NameAddressID/FEIBusiness Operations
SAMSUNG PHARM IND. CO., LTD.687744425manufacture(49789-060)

Revised: 4/2013
Document Id: b1cce823-c1c1-4653-8047-fbc087977c58
Set id: d2b9e29f-7cc8-470b-9546-9614f8eda199
Version: 1
Effective Time: 20130403
 
SAMSUNG PHARM IND. CO., LTD.