Drugplain

Zephrex D 30 mg/1

pseudoephedrine hydrochloride · CAPSULE, GELATIN COATED · L. Perrigo Company

1 Recall on Record
Plain English

Zephrex D is a capsule, gelatin coated containing pseudoephedrine hydrochloride at 30 mg/1, taken oral. Manufactured by L. Perrigo Company.

Key Facts

Brand Name
Zephrex D
Generic Name
pseudoephedrine hydrochloride
NDC Code (Product)
0113-0401
Manufacturer
L. Perrigo Company
Strength
30 mg/1
Dosage Form
CAPSULE, GELATIN COATED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
11/04/2016

Recall History

1 Recall on Record
Class II11/08/2017

L. Perrigo Company

Microbial Contamination of Non-Sterile Products

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

systemic lupus erythematosus5,132 reports
pain5,079 reports
drug ineffective5,042 reports
pemphigus5,019 reports
rheumatoid arthritis5,005 reports
abdominal discomfort4,928 reports
alopecia4,848 reports
glossodynia4,668 reports
wound4,493 reports
swelling4,486 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure

Dosage & Administration

Directions adults and children 12 years and over • take 2 softgels every 4 to 6 hours • do not take more than 8 softgels in 24 hours children ages 6 to under 12 years • take 1 softgel every 4 to 6 hours • do not take more than 4 softgels in 24 hours children under 6 years do not use this product in children under 6 years of age

Warnings

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 occurs • 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).

Frequently Asked Questions

What is Zephrex D used for?

Zephrex D contains pseudoephedrine hydrochloride. It is a capsule, gelatin coated taken oral. Consult your doctor for specific uses.

Is Zephrex D a controlled substance?

Zephrex D is not classified as a controlled substance by the DEA.

What is the generic name for Zephrex D?

The generic name for Zephrex D is pseudoephedrine hydrochloride. There are 11 other brand versions of pseudoephedrine hydrochloride.

What is the NDC code for Zephrex D 30 mg/1?

The NDC (National Drug Code) for Zephrex D 30 mg/1 is 0113-0401, listed by L. Perrigo Company.