Label: HANPOONG GAL CHEON XIN EXTRACT GRANULES- ephedrine hci bead
- NDC Code(s): 82369-1104-1, 82369-1104-2
- Packager: HANPOONG PHARM 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 November 3, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Asthma alert: Because asthma may be life threatening, see a doctor if you
■ are not better in 60 minutes
■ get worse
■ need more than 32 sachets in 24 hours
■ use more than 21 sachets in 24 hours for 3 or more days a week
■ have more than 2 asthma attacks in a week
■ These may be signs that your asthma is getting worse.
■ This product will not give you asthma relief as quickly as an inhaled bronchodilator. -
DO NOT USE
■ unless a doctor said you have asthma
■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
WHEN USING
■ your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.
■ your risk of heart attack or stroke increases if you: ■ have a history of high blood pressure or heart disease ■ take this product more frequently or take more than the recommended dose ■ avoid foods or beverages that contain caffeine ■ avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect - STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HANPOONG GAL CHEON XIN EXTRACT GRANULES
ephedrine hci beadProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82369-1104 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE 4.6 mg in 4 g Inactive Ingredients Ingredient Name Strength CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J) LICORICE (UNII: 61ZBX54883) MAGNOLIA SPRENGERI FLOWER BUD (UNII: 138CR0TWEI) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) SUCROSE STEARATE (UNII: 274KW0O50M) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) STARCH, CORN (UNII: O8232NY3SJ) GINGER (UNII: C5529G5JPQ) CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EPHEDRA SINICA STEM (UNII: 55L3XLO37E) JUJUBE FRUIT (UNII: G55HNL2C70) Product Characteristics Color brown Score score with uneven pieces Shape Size 1mm Flavor ANISE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82369-1104-1 120 in 1 BOX 01/01/2022 1 NDC:82369-1104-2 4 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2022 Labeler - HANPOONG PHARM CO.,LTD. (631169612) Establishment Name Address ID/FEI Business Operations HANPOONG PHARM CO.,LTD. 631169612 manufacture(82369-1104)