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Pseudoephedrine hydrochloride - Medication Information

Product NDC Code 53943-204
Drug Name

Pseudoephedrine hydrochloride

Type Generic
Pharm Class Adrenergic alpha-Agonists [MoA],
alpha-Adrenergic Agonist [EPC]
Active Ingredients
Pseudoephedrine hydrochloride 120 mg/1
Route ORAL
Dosage Form TABLET, EXTENDED RELEASE
RxCUI drug identifier 1049154
Application Number ANDA077442
Labeler Name DISCOUNT DRUG MART
Packages
Package NDC Code Description
53943-204-10 1 blister pack in 1 carton (53943-204-10) / 10 tablet, extended release in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Pseudoephedrine HCl, USP 120 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age
adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours
children under 12 years do not use this product in children under 12 years of age

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

Purpose

Information about the drug product’s indications for use.
Purpose Nasal decongestant

Spl product data elements

Usually a list of ingredients in a drug product.
Pseudoephedrine hydrochloride Pseudoephedrine hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CASTOR OIL SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE TITANIUM DIOXIDE 204

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton DISCOUNT drug mart FOOD FAIR MAY CONTAIN ANTI-THEFT DEVICE Non-Drowsy 12 Hour Nasal Decongestant Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablets, USP 12 Hour Long-Acting Nasal Decongestant *Compare to the active ingredient of SUDAFED ® 12 Hour ✓ SINUS PRESSURE + CONGESTION ✓ MAXIMUM STRENGTH 10 Coated Capsule-Shaped Tablets (120 mg each) PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts DISTRIBUTED BY DRUG MART-FOOD FAIR MEDINA, OHIO 44256

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use 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.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? call 1-800-406-7984

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not exceed recommended dosage

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 59° to 77° F in a dry place. Protect from light TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Do not use 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 heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API