Cabinet Non Drowsy Allergy Relief, Fexofenadine

Cabinet Non Drowsy Allergy Relief, Fexofenadine
SPL v2
SPL
SPL Set ID 5237c8bd-0b20-4639-a740-f3001c4c2c94
Route
ORAL
Published
Effective Date 2025-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: G6 Shape: capsule Color: pink Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2025-09-01

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 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

Do Not Use

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

Other Information
  •  safety sealed: do not use if imprinted foil under bottle cap is opened or torn
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
Package Labeling:

Active Ingredient 

Fexofenadine HCl USP, 180 mg

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch

Questions Or Comments?

contact 1-908-242-6108Mon-Fri 8:00 AM to 5:00 PM EST

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.


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 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

Do Not Use (Do not use)

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

Other Information (Other information)
  •  safety sealed: do not use if imprinted foil under bottle cap is opened or torn
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
Package Labeling:

Active Ingredient  (Active ingredient )

Fexofenadine HCl USP, 180 mg

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch

Questions Or Comments? (Questions or comments?)

contact 1-908-242-6108Mon-Fri 8:00 AM to 5:00 PM EST

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.


Advanced Ingredient Data


Raw Label Data

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