RED LABEL EPHEDRINE PLUS- ephedrine hydrochloride, guaifenesin tablet

Red Label Ephedrine Plus by

Drug Labeling and Warnings

Red Label Ephedrine Plus by is a Otc medication manufactured, distributed, or labeled by Dickey Consumer Products DBA DMD, Ultratab Laboratories, Inc., Ultra Seal Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient(In Each Tablet): Ephedrine HCl 12.5 mg, Guaifenesin 200 mg

PURPOSE

Purposes - Bronchodilator, Expectorant

INDICATIONS & USAGE

for temporary relief of mild symptoms of intermittent asthma:  wheezing tightness of chest shortness of breath. Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive.

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 12 tablets in 24 hours  use more than 8 tablets 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 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 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 a doctor before use if you have: ever been hospitalized for asthma heart disease high blood pressure diabetes  thyroid disease seizures narrow angle glaucoma  a psychiatric or emotional condition  trouble urinating due to an enlarged prostate gland  cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Ask a doctor or pharmacist before use if you are: taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions.  Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)

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 claim to have a stimulant effect.  

Stop use and ask a doctor if:  your asthma is getting worse (see Asthma alert)  you have difficulty sleeping  you have a rapid heart beat  you have tremors, nervousness or seizures cough lasts more than 1 week, comes back, or occurs with fever, rash, or persistent headache.  These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

do not take more than directed  adults and children 12 years of age and over: oral dose is 1-2 tablets every 4 hours as needed, do not take more than 12 tablets in 24 hours children under 12 years of age: do not use

INACTIVE INGREDIENT

Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate,Stearic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RED LABEL EPHEDRINE PLUS 
ephedrine hydrochloride, guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65193-125
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS)	EPHEDRINE HYDROCHLORIDE	12.5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	white (snow white)	Score	no score
Shape	ROUND (EP125)	Size	9mm
Flavor		Imprint Code	EP125
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65193-125-48	48 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/02/2019

Labeler - Dickey Consumer Products DBA DMD (835974056)

Registrant - Dickey Consumer Products DBA DMD (835974056)

Establishment
Name	Address	ID/FEI	Business Operations
Ultratab Laboratories, Inc.		151051757	manufacture(65193-125)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corp.		085752004	pack(65193-125)