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NDC 00363-2529-67 Bronchial Asthma Relief 12.5; 200 mg/1; mg/1 Details
Bronchial Asthma Relief 12.5; 200 mg/1; mg/1
Bronchial Asthma Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is EPHEDRINE HYDROCHLORIDE; GUAIFENESIN.
Product Information
| NDC | 00363-2529 |
|---|---|
| Product ID | 0363-2529_bcb71dc3-3e98-de10-e053-2a95a90a41ac |
| Associated GPIs | 43996202050320 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Bronchial Asthma Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ephedrine HCl, Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 12.5; 200 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | EPHEDRINE HYDROCHLORIDE; GUAIFENESIN |
| Labeler Name | Walgreen Company |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Norepinephrine Activity [PE], Increased Respiratory Secretions [PE], Norepinephrine Releasing Agent [EPC], alpha- |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 00363-2529-67 (00363252967)
| NDC Package Code | 0363-2529-67 |
|---|---|
| Billing NDC | 00363252967 |
| Package | 4 BLISTER PACK in 1 CARTON (0363-2529-67) / 15 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2002-02-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 10816e9d-0c53-424b-b482-fdd01a4d8525 Details
USES
WARNINGS
Asthma alert: Because asthma may be life threatening, see a doctor if you
- are not better in 60 minutes
- get worse
- need 12 tablets in any day
- use more than 8 tablets a day for more than 3 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 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
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 enlargement of the 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 DOCTOR/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)
STOP USE
and ask a doctor if
- your asthma is getting worse (see Asthma alert)
- you have difficulty sleeping
- you have rapid heartbeat
- you have tremors, nervousness, or seizure
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
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
DOSAGE AND ADMINISTRATION
SPL UNCLASSIFIED SECTION
INACTIVE INGREDIENT
SPL UNCLASSIFIED SECTION
Intentional abuse of this product can be harmful or fatal
Distribution of this product requires a DEA License
Tamper evident: Do Not USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN
GLUTEN FREE
‡Walgreens Pharmacist Survey Study, November 2010
#This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Primatene®
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| BRONCHIAL ASTHMA RELIEF
ephedrine hcl, guaifenesin tablet |
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| Labeler - Walgreen Company (008965063) |
| Registrant - Contract Pharmacal Corp. (057795122) |
Revised: 11/2022
Document Id: bcb71dc3-3e98-de10-e053-2a95a90a41ac
Set id: 10816e9d-0c53-424b-b482-fdd01a4d8525
Version: 4
Effective Time: 20221110