Label: HANPOONG BEAT COLD- ephedrine hci tablet
- NDC Code(s): 82369-1111-1, 82369-1111-2
- 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 10, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WHEN USING
-
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 28 sachets in 24 hours
■ use more than 18 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
When using this product
■ 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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Croscarmellose sodium, Herbal extract (Cinnamomum cassia, Ephedra, Ginger, Jujube, Kudzu, Licorice, Paeonia lactiflora root), Hypromellose, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol 6000, Silicon dioxide, Titanium oxide,
FD&C Blue No. 1, FD&C Red No. 40, Food Yellow No.5 Aluminium Lake - QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HANPOONG BEAT COLD
ephedrine hci tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82369-1111 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE 5.34 mg in 8 g Inactive Ingredients Ingredient Name Strength JUJUBE FRUIT (UNII: G55HNL2C70) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GINGER (UNII: C5529G5JPQ) LICORICE (UNII: 61ZBX54883) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) EPHEDRA SINICA STEM (UNII: 55L3XLO37E) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color pink Score 2 pieces Shape OVAL Size 18mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82369-1111-1 1 in 1 BOX 01/01/2022 1 NDC:82369-1111-2 16 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 part349 01/01/2022 Labeler - HANPOONG PHARM CO.,LTD. (631169612) Establishment Name Address ID/FEI Business Operations HANPOONG PHARM CO.,LTD. 631169612 manufacture(82369-1111)