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Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

Also sold as Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

From 2 official FDA drug labels · RxNorm 997406

This comes from U.S. FDA labels. Brand names, strengths and advice can differ in your country; check with a local health professional. Set your country.

What it is used for

These are the uses the FDA has approved for this label. Using it for anything else is “off-label”: ask your prescriber why.

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

How to take it

Directions do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

Do not take it if

Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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. if you have difficulty swallowing

Ask a doctor or pharmacist before using it if

Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. Your doctor should determine if you need a different dose.

Serious warnings and precautions

Warnings

When using this product

When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)

Stop using it and ask a doctor if

Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless

If you are pregnant or breastfeeding

If pregnant or breast-feeding ask a health professional 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.

Forms and strengths available

180 MG · Oral Tablet30 MG · Disintegrating Oral Tablet30 MG · Oral Tablet6 MG/ML · Oral Suspension60 MG · Oral Capsule60 MG · Oral Tablet120 MG · Oral Tablet

From RxNorm. Which forms and strengths are actually stocked varies by pharmacy and country.

Reactions people have reported

pruritus 4condition aggravated 2angioedema 2haematocrit decreased 2insomnia 2haemoglobin decreased 2drug ineffective 2chronic spontaneous urticaria 2rash 1dyskinesia 1

These are counts from 8 voluntary reports to the FDA. They show what has been reported — they are not how common a side effect is, and they do not prove the medicine caused it.

Recalls

Class II · Jan 31, 2024
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Jul 19, 2023
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007.
Reason: Failed Impurities/Degradation Specifications
Class II · Jul 19, 2023
allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811.
Reason: Failed Impurities/Degradation Specifications
Class II · Jul 19, 2023
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
Reason: Failed Impurities/Degradation Specifications
Class II · Jul 19, 2023
Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78
Reason: Failed Impurities/Degradation Specifications
Class II · Jul 19, 2023
Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury, NC 28147. NDC 72476-847-22
Reason: Failed Impurities/Degradation Specifications
Class II · Jul 19, 2023
Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.
Reason: Failed Impurities/Degradation Specifications
Class II · Jul 19, 2023
Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons (NDC 72288-847-47 and 72288-847-37), Distributed By: Amazon.com Services LLC., 410 Terry Avenue N., Seattle, WA 98109.
Reason: Failed Impurities/Degradation Specifications

Research & studies

Recent higher-quality studies about Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride, from PubMed. We link to the source — titles only. This is not medical advice.

Similar medicines

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride belongs to the Other antihistamines for systemic use class. Other medicines in it:

Questions to ask your doctor or pharmacist

Why you can trust this

Everything above comes from official FDA drug labels (openFDA), not written by us. Here are the exact labels used.

This information explains the official label. It cannot tell you whether this medicine is right or safe for you personally — only a qualified health professional who knows your history can do that. Do not start, stop, or change a medicine based on this page alone.