Allergy Relief

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl 180mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
• runny nose  
• itchy, watery eyes  
• sneezing  
• itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

• 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)

Stop use and ask a doctor if

OTC - STOP USE SECTION

if an allergic reaction to this product occurs. Seek medical help right away.

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over	take one 180 mg tablet with water, once a   day; 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

SPL UNCLASSIFIED SECTION

• store at room temperature 20°– 25°C  (68°– 77°F) 
• protect from excessive moisture 
• do not use if imprinted seal under safety cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, yellow iron oxide  

Questions

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

• Allergy Relief
• Fexofenadine HCl
• FEXOFENADINE HYDROCHLORIDE
• FEXOFENADINE
• ANHYDROUS LACTOSE
• SILICON DIOXIDE
• STARCH, CORN
• CROSCARMELLOSE SODIUM
• HYPROMELLOSE, UNSPECIFIED
• LACTOSE MONOHYDRATE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• FERRIC OXIDE RED
• STEARIC ACID
• TITANIUM DIOXIDE
• FERRIC OXIDE YELLOW

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.