EPHED ASTHMA- ephedrine hydrochloride, guaifenesin tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Available from:
Dickey Consumer Products DBA DMD
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purposes - Bronchodilator, Expectorant • 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.
Authorization status:
OTC monograph final
Authorization number:
65193-320-24

EPHED ASTHMA- ephedrine hydrochloride, guaifenesin tablet

Dickey Consumer Products DBA DMD

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.

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DRUG FACTS

Active Ingredient(In Each Tablet): Ephedrine HCl 25 mg, Guaifenesin 200 mg

Purposes - Bronchodilator, Expectorant

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.

Asthma Alert: because asthma may be life threatening, see a doctor if you: Are not better in 60

minutes get worse need more than 6 tablets in 24 hours use more than 4 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 food 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.

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

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

Center right away.

do not take more than directed adults and children 12 years of age and over: 1 tablet every 4 hours as

needed, do not take more than 6 tablets in 24 hours children under 12 years of age: do not use

Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch

Glycolate,Stearic Acid

EPHED ASTHMA

ephedrine hydrochloride, guaifenesin tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 519 3-320

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

EPHEDRINE HYDRO CHLO RIDE (UNII: NLJ6 39 0 P1Z) (EPHEDRINE - UNII:GN8 3C131XS)

EPHEDRINE HYDROCHLORIDE 25 mg

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PO VIDO NE K3 0 (UNII: U725QWY32X)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics

Color

white (sno w white)

S core

4 pieces

S hap e

ROUND (EP225)

S iz e

9 mm

Flavor

Imprint Code

EP225

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 519 3-320 -24 24 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

12/13/20 11

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

12/13/20 11

Labeler -

Dickey Consumer Products DBA DMD (835974056)

Registrant -

Dickey Consumer Products DBA DMD (835974056)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ultratab Labo rato ries, Inc.

1510 51757

ma nufa c ture (6 519 3-320 )

Establishment

Dickey Consumer Products DBA DMD

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ultra Seal Co rp.

0 8 57520 0 4

pa c k(6 519 3-320 )

Revised: 3/2019

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