Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2f47e993-1668-6904-e063-6394a90a064c
Route
ORAL
Published
Effective Date 2019-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Paeonia Lactiflora Root (1.9 g) Ginger Licorice
Inactive Ingredients
Lactose Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-03-01

Description

Dry Ginger 1.90g Glycyrrhiza 1.90g Peony Root 1.90g


Medication Information

Warnings and Precautions

Warnings

When using this product

■Do not use in patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption since this drug contains lactose.

■Do not use it for more than 1 month unless the symptoms improve. Long-term use should only be done under medical supervision.

■When used in combination with potassium-containing agents, licorice-containing drugs, and diuretics (e.g., furosemide, ethacrynic acid, trichlormethiazide), myopathy is likely to occur, so take it carefully.

■When combined with MaHuang or ephedrine-containing agents, MAO inhibitors, thyroid agents(thyroxine, liothyronine), catecholamine agents(epinephrine, isoprenaline), and xanthin agents(theophylline, dipropylene), symptoms such as insomnia, excessive sweat, rapid pulse, frequent urination, palpitations, general weakness, and mental excitement are likely to appear, so take them carefully.

Ask a doctor before use if you have high blood pressure, edema, heart or kidney problems, rash, redness, diabetic, another disease.

Stop use and ask a doctor if the following serious side effects occur. These may be signs of a serious condition.

■Gastric aldosteronism (decreased urine, swollen face, hands, feet, eyelids, etc.)

■Myopathy (muscle weakness, cramps, paralysis)

■Interstitial pneumonia (fever, cough, shortness of breath, lung sound abnormalities)

■Liver disorders (elevated liver enzymes, jaundice)

■Skin reactions (rash, hives)

■Digestive issues (loss of appetite, stomach discomfort)

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children, In case of overdose, get medical help or contact a poison control center right away

Indications and Usage

■ Take a packet of medicine (one dose) of an adult three times a day before or between meals.

Dosage and Administration

for oral use only

Description

Dry Ginger 1.90g Glycyrrhiza 1.90g Peony Root 1.90g

Section 50565-1

keep out of reach of the children

Section 51727-6

corn starch, Lactose Hydrate

Section 51945-4

Section 55105-1

■Bronchitis, Bronchial asthma, Coryza, Runny nose, Cough with dilute phlegm, rhinitis

Section 55106-9

Dry Ginger 1.90g

Glycyrrhiza 1.90g

Peony Root 1.90g


Structured Label Content

Indications and Usage (34067-9)

■ Take a packet of medicine (one dose) of an adult three times a day before or between meals.

Dosage and Administration (34068-7)

for oral use only

Warnings and Precautions (34071-1)

Warnings

When using this product

■Do not use in patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption since this drug contains lactose.

■Do not use it for more than 1 month unless the symptoms improve. Long-term use should only be done under medical supervision.

■When used in combination with potassium-containing agents, licorice-containing drugs, and diuretics (e.g., furosemide, ethacrynic acid, trichlormethiazide), myopathy is likely to occur, so take it carefully.

■When combined with MaHuang or ephedrine-containing agents, MAO inhibitors, thyroid agents(thyroxine, liothyronine), catecholamine agents(epinephrine, isoprenaline), and xanthin agents(theophylline, dipropylene), symptoms such as insomnia, excessive sweat, rapid pulse, frequent urination, palpitations, general weakness, and mental excitement are likely to appear, so take them carefully.

Ask a doctor before use if you have high blood pressure, edema, heart or kidney problems, rash, redness, diabetic, another disease.

Stop use and ask a doctor if the following serious side effects occur. These may be signs of a serious condition.

■Gastric aldosteronism (decreased urine, swollen face, hands, feet, eyelids, etc.)

■Myopathy (muscle weakness, cramps, paralysis)

■Interstitial pneumonia (fever, cough, shortness of breath, lung sound abnormalities)

■Liver disorders (elevated liver enzymes, jaundice)

■Skin reactions (rash, hives)

■Digestive issues (loss of appetite, stomach discomfort)

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children, In case of overdose, get medical help or contact a poison control center right away

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

corn starch, Lactose Hydrate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

■Bronchitis, Bronchial asthma, Coryza, Runny nose, Cough with dilute phlegm, rhinitis

Section 55106-9 (55106-9)

Dry Ginger 1.90g

Glycyrrhiza 1.90g

Peony Root 1.90g


Advanced Ingredient Data


Raw Label Data

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