Active Ingredient(S)
Fexofenadine HCl USP, 60 mg
Pseudoephedrine HCl USP,120 mg
Fexofenadine Hcl And Pseudoephedrine Hci Tablet, Extended Release
FDA Label NDC 55111-447
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Limited for the product Fexofenadine Hcl And Pseudoephedrine Hci (NDC 55111-447). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Nasal decongestant
Use(S)
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- nasal congestion
- itchy, watery eyes
- itching of the nose or throat
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
Warnings
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 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.
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)
- the tablet coating may be seen in the stool (this is normal). Continue to takeas directed (see Directions).
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
Pregnancy/Breastfeeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contacta Poison Control Center right away.
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 |
Other Information
- safety sealed: do not use if carton is opened or if individual blister units are torn or opened
- this product meets the requirements of USP dissolution test 3.
Storage
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose, and triethyl citrate.
Questions Or Comments?
call toll-free 1-888-375-3784
Manufactured by:
Dr. Reddy’s Laboratories Limited
Bachupally - 500 090 INDIA
Principal Display Panel
Blister carton 20's (4x5 unit-dose)
Carton (Carton)
* Please review the disclaimer below.
