Label: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL tablet, extended release
- NDC Code(s): 51316-018-10, 51316-018-15
- Packager: CVS Pharmacy, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 28, 2024
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- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
-
Use(s)
- 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
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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 take as directed (see Directions).
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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 24 hours on an empty stomach; do not take more than 1 tablet 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
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Inactive ingredients
acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, red iron oxide, sodium chloride, talc, titanium dioxide, water
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL
fexofenadine hcl and pseudoephedrine hcl tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-018 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 180 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 240 mg Inactive Ingredients Ingredient Name Strength ACETONE (UNII: 1364PS73AF) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CELLULOSE ACETATE (UNII: 3J2P07GVB6) COPOVIDONE (UNII: D9C330MD8B) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISOPROPYL ALCOHOL (UNII: ND2M416302) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MAGNESIUM STEARATE (UNII: 70097M6I30) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) FERRIC OXIDE RED (UNII: 1K09F3G675) POVIDONE K30 (UNII: U725QWY32X) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE Score no score Shape ROUND Size 12mm Flavor Imprint Code 892 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-018-10 2 in 1 CARTON 11/30/2022 1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:51316-018-15 3 in 1 CARTON 11/30/2022 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 ANDA079043 11/30/2022 Labeler - CVS Pharmacy, Inc (062312574) Establishment Name Address ID/FEI Business Operations Dr.Reddy's Laboratories Limited (FTO III) 918608162 analysis(51316-018) , manufacture(51316-018)
