Label: FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated, extended release
- NDC Code(s): 51660-037-21, 51660-037-31
- Packager: Ohm Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 13, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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:
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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)
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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 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 or comments?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
†Compare To
the active ingredients of
Allegra-D®NDC 51660-037-21
ohm®
NON-DROWSY
Original Prescription Strength
Fexofenadine HCl 60 mg/Antihistamine
Pseudoephedrine HCl 120 mg/Nasal Decongestant
Extended-Release Tablets, USPAllergy & Congestion
Indoor and Outdoor Allergies
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
12 Hour
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
20 Extended-Release Tablets
- Nasal and 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:51660-037 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 CAPSULE (bilayer) Size 17mm Flavor Imprint Code 724 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51660-037-21 1 in 1 CARTON 03/01/2018 1 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:51660-037-31 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 - Ohm Laboratories Inc. (184769029) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 650445203 ANALYSIS(51660-037) , MANUFACTURE(51660-037)