Label: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated, extended release
- NDC Code(s): 69842-990-20, 69842-990-30
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 31, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
-
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
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- 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
- When using this product
- Stop use and ask doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
-
Directions
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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
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 60 mg/120 mg Tablet Blister Pack Carton
CVSHealth™
Compare to the active ingredients in Allegra-D®*
Indoor & Outdoor Allergies
Original Prescription Strength
ALLERGY & CONGESTION RELIEFAllergy Relief D
FEXOFENADINE HCl 60 mg/Antihistamine
PSEUDOEPHEDRINE HCl 120 mg/Nasal decongestant
EXTENDED RELEASE TABLETS, USP12
HOUR12 Hour Relief of:
- Nasal & sinus congestion
due to colds or allergies - Sneezing; Runny nose; Itchy,
watery eyes & Itchy nose
or throat due to allergies
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
Non-Drowsy
20 EXTENDED-RELEASE TABLETS
Actual Size
- Nasal & sinus congestion
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-990 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONE K30 (UNII: U725QWY32X) MAGNESIUM STEARATE (UNII: 70097M6I30) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE, YELLOW Score no score Shape OVAL (bilayer) Size 17mm Flavor Imprint Code 724 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-990-20 1 in 1 CARTON 03/01/2018 1 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:69842-990-30 1 in 1 CARTON 03/01/2018 2 30 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 ANDA090818 03/01/2018 Labeler - CVS Pharmacy (062312574) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 650445203 ANALYSIS(69842-990) , MANUFACTURE(69842-990)