Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID f43a08ec-e670-4043-af6e-60d3e0aadd59
Route
ORAL
Published
Effective Date 2024-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromelloses Ferric Oxide Red Ferric Oxide Yellow Lactose Monohydrate Polyethylene Glycol, Unspecified Titanium Dioxide Anhydrous Lactose Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: SG;202 Shape: capsule Color: pink Size: 17 mm Score: 1
Marketing Status
ANDA Completed Since 2021-04-30 Until 2026-04-30

Description

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP 180 mg

Uses

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
Directions
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 


Do Not Use

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

Product Label
SOUNDBODY Allergy Relief
Other Information
  • 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

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?

Call 1-877-770-3183

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

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).

Ask A Doctor Before Use If You Have

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

Active Ingredient (in Each Film Coated tablet)

Fexofenadine HCl USP 180 mg


Structured Label Content

Uses

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
Purpose

Antihistamine

Directions
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 


Do Not Use (Do not use)

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

Product Label
SOUNDBODY Allergy Relief
Other Information (Other information)
  • 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 ingredients)

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? (Questions or comments?)

Call 1-877-770-3183

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

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).

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.

Active Ingredient (in Each Film Coated tablet) (Active ingredient (in each film-coated tablet))

Fexofenadine HCl USP 180 mg


Advanced Ingredient Data


Raw Label Data

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