Label: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated, extended release
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NDC Code(s):
47335-724-60,
47335-724-64,
47335-724-66,
47335-724-75, view more47335-724-83, 47335-724-94, 47335-724-95, 47335-724-99
- Packager: Sun Pharmaceutical Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 11, 2025
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
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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
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Do not use
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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
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- 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
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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?
- Principal Display Panel
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Principal Display Panel-Showbox
NDC 47335-724-94
ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY
Fexofenadine HCI and Pseudoephedrine HCI Extended-Release Tablets, USP
60 mg/120 mg
ALLERGY & CONGESTION
12 HR
Antihistamine/Nasal Decongestant
10 Extended-Release Tablets
INDOOR / OUTDOOR RELIEF OF
• Nasal and Sinus Congestion Due to Colds or Allergies
• Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
SUN PHARMA
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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:47335-724 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) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONE K30 (UNII: U725QWY32X) MAGNESIUM STEARATE (UNII: 70097M6I30) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE, YELLOW Score no score Shape CAPSULE (bilayer) Size 17mm Flavor Imprint Code 724 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47335-724-83 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2018 2 NDC:47335-724-94 1 in 1 CARTON 03/01/2018 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:47335-724-99 2 in 1 CARTON 03/01/2018 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:47335-724-95 3 in 1 CARTON 03/01/2018 4 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 5 NDC:47335-724-66 2 in 1 CARTON 03/01/2018 5 NDC:47335-724-60 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 6 NDC:47335-724-75 4 in 1 CARTON 03/01/2018 6 NDC:47335-724-60 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 7 NDC:47335-724-64 6 in 1 CARTON 03/01/2018 7 NDC:47335-724-60 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 ANDA090818 03/01/2018 Labeler - Sun Pharmaceutical Industries, Inc. (146974886) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 650445203 ANALYSIS(47335-724) , MANUFACTURE(47335-724)