Active Ingredient
Active ingredient: Calcium carbonate 350mg
His Ulc Mint Blue
FDA Label NDC 49789-060
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Samsung Pharm Ind. Co., Ltd. for the product His Ulc Mint Blue (NDC 49789-060). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications and usage, dosage and administration, package label. principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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