Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 0c83f650-f2bf-4c5b-a1e3-7c40cd9c4c6f
Route
ORAL
Published
Effective Date 2023-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (60 mg)
Inactive Ingredients
Silicon Dioxide Hypromelloses Ferric Oxide Red Ferric Oxide Yellow Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Titanium Dioxide Polysorbate 80 Starch, Corn Light Mineral Oil Talc Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance
Imprint: J;43 Shape: capsule Color: pink Size: 12 mm Score: 1
Marketing Status
ANDA Active Since 2019-10-01
Description

Fexofenadine HCl USP 60 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP 60 mg

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
Directions
adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; 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
Do Not Use

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

Product Label
Allergy Relief
Other Information
  • Tamper Evident: do not use if printed safety seal under cap is broken or missing
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture



Inactive Ingredients

colloidal silicon dioxide, hypromellose, light liquid paraffin,magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, and yellow iron oxide

Principal Display Panel

*Compare to the active ingredient in Allegra® Allergy 12 hour

Allergy Relief

Fexofenadine HCL USP 180 mg

 Antihistamine

12 HOUR RELIEF OF:

  • Sneezing
  • Runny Nose
  • Itchy, Water Eyes
  • Itchy Throat or Nose

Caplets**

(**Capsule-shaped Tablets)

*This product is not manufactured or distributed by Chattem, Inc., distributor of Allegra® Allergy 12 hour.

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

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)
Stop Use and Ask A Doctor If

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Fexofenadine HCl USP 60 mg

Ask A Doctor Before Use If You Have

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

Structured Label Content

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
Purpose

Antihistamine

Directions
adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; 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
Do Not Use (Do not use)

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

Product Label
Allergy Relief
Other Information (Other information)
  • Tamper Evident: do not use if printed safety seal under cap is broken or missing
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture



Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, light liquid paraffin,magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, and yellow iron oxide

Principal Display Panel

*Compare to the active ingredient in Allegra® Allergy 12 hour

Allergy Relief

Fexofenadine HCL USP 180 mg

 Antihistamine

12 HOUR RELIEF OF:

  • Sneezing
  • Runny Nose
  • Itchy, Water Eyes
  • Itchy Throat or Nose

Caplets**

(**Capsule-shaped Tablets)

*This product is not manufactured or distributed by Chattem, Inc., distributor of Allegra® Allergy 12 hour.

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

When Using This Product (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)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCl USP 60 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:31.896695 · Updated: 2026-03-14T23:01:00.090870