Label: ALLEGRA-D ALLERGY AND CONGESTION- fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
- NDC Code(s): 41167-4320-3, 41167-4320-5, 41167-4320-7
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 3, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Active ingredients
- 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:
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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).
- if you have ever had an allergic reaction to this product or any of its ingredients
-
Directions
- do not divide, crush, chew or dissolve the tablet; swallow tablet whole
adults and children 12 years
of age and overtake 1 tablet with a glass of water
every 24 hours on an empty stomach; do
not take more than 1 tablet in 24 hourschildren 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
acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, glycerol triacetate, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, povidone, sodium chloride, talc, titanium dioxide, water
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALLEGRA-D ALLERGY AND CONGESTION
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-4320 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 ALUMINUM OXIDE (UNII: LMI26O6933) TRIACETIN (UNII: XHX3C3X673) ACETONE (UNII: 1364PS73AF) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CELLULOSE ACETATE (UNII: 3J2P07GVB6) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) COPOVIDONE K25-31 (UNII: D9C330MD8B) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE (UNII: FZ989GH94E) SODIUM CHLORIDE (UNII: 451W47IQ8X) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score no score Shape ROUND Size 19mm Flavor Imprint Code 308;AV Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-4320-3 1 in 1 CARTON 03/03/2011 03/01/2019 1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:41167-4320-5 2 in 1 CARTON 03/03/2011 2 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:41167-4320-7 3 in 1 CARTON 03/03/2011 3 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 NDA NDA021704 03/03/2011 Labeler - Chattem, Inc. (003336013)