HIS ULC MINT BLUE- calcium carbonate tablet, chewable

HIS ULC MINT BLUE by

Drug Labeling and Warnings

HIS ULC MINT BLUE by is a Otc medication manufactured, distributed, or labeled by SAMSUNG PHARM IND. CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HIS ULC MINT BLUE 
calcium carbonate tablet, chewable

Product 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)