Allergy Relief

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each film-coated tablet)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP 180 mg

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 you have

OTC - ASK DOCTOR SECTION

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

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

If pregnant or breast-feeding,

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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over	take one 18 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

STORAGE AND HANDLING SECTION

• each tablet contains: sodium 8 mg
• store between 20-25ºC (68-77ºF)
• protect from excessive moisture
• this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-770-3183

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Allegra® Allergy 24 hour

Original Prescription Strength • NON-DROWSY

Allergy Relief

Fexofenadine HCI 180mg

Antihistamine Indoor & Outdoor Allergies

24 Hour Relief of: Sneezing; Runny Nose;

Itchy, Watery Eyes; Itchy Nose or Mouth

COATED CAPLETS**

(**Capsule-Shaped Tablets

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 Hour.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

Big Lots Stores, Inc.

P.O. Box 28523

Columbus, OH 43228-0523

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
• SILICON DIOXIDE
• CROSCARMELLOSE SODIUM
• HYPROMELLOSES
• FERRIC OXIDE RED
• FERRIC OXIDE YELLOW
• LACTOSE MONOHYDRATE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• TITANIUM DIOXIDE
• ANHYDROUS LACTOSE
• STARCH, CORN
• STEARIC ACID

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 · 176 observed states.

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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.