Label: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI- fexofenadine hcl and pseudoephedrine hci tablet, extended release
- NDC Code(s): 43598-823-14, 43598-823-31
- Packager: Dr. Reddy's Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated July 18, 2019
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- Active ingredient(s)
Fexofenadine HCl USP, 60 mg
Pseudoephedrine HCl USP,120 mgClose
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
- temporarily relives 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
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
- high blood pressure
- 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 take as 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
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- store between 20° to 25°C (68° to 77°F) store between 20° to 25°C (68° to 77°F)
- this product meets the requirements of USP dissolution test 3.
- Inactive ingredients
corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose and triethyl citrate.Close
Dr. Reddy’s Laboratories, Inc.
Princeton, NJ 08540
Made in IndiaClose
- Principal Display Panel
- INGREDIENTS AND APPEARANCE
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI
fexofenadine hcl and pseudoephedrine hci tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43598-823 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength MANNITOL (UNII: 3OWL53L36A) POWDERED CELLULOSE (UNII: SMD1X3XO9M) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSES (UNII: 3NXW29V3WO) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color WHITE (buff white to pale yellow color and other layer light red to red color) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code R;195 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43598-823-14 4 in 1 CARTON 07/18/2019 1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:43598-823-31 6 in 1 CARTON 07/18/2019 2 5 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076667 07/18/2019 Labeler - Dr. Reddy's Laboratories Inc. (802315887) Establishment Name Address ID/FEI Business Operations Dr. Reddy's Laboratories Limited (FTO III) 918608162 analysis(43598-823) , manufacture(43598-823) Establishment Name Address ID/FEI Business Operations Reed Lane, Inc 001819879 repack(43598-823)