413 - Allery Relief

413 - Allery Relief
SPL v6
SPL
SPL Set ID 25e72bd3-25c6-4943-92bb-27f9543e2d8a
Route
ORAL
Published
Effective Date 2021-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Ferrosoferric Oxide Hypromellose, Unspecified Ferric Oxide Red Ferric Oxide Yellow Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G6 Shape: capsule Color: pink Size: 18 mm
Marketing Status
ANDA Active Since 2021-03-22

Description

Fexofenadine HCl 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl 180 mg

Use(s)

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

Storage

store at room temperature 20°– 25°C (68°– 77°F)

Questions

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



Directions

Adults and children 12 years of age and over  take one 180 mg caplet with water, once a day; do not take more than 1 caplet 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
  • protect from excessive moisture
  • do not use if imprinted seal under safety cap is broken or missing [for bottle]
  • do not use if blister unit is torn or open [for blister]

Active Ingredient(s)

Fexofenadine HCl 180 mg

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxide (black iron oxide),

hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate,

microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel
Allergy Relief
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)

Ask A Doctor Before Use If

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

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children

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


Structured Label Content

Use(s)

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

Storage

store at room temperature 20°– 25°C (68°– 77°F)

Questions

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



Directions

Adults and children 12 years of age and over  take one 180 mg caplet with water, once a day; do not take more than 1 caplet 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)
  • protect from excessive moisture
  • do not use if imprinted seal under safety cap is broken or missing [for bottle]
  • do not use if blister unit is torn or open [for blister]

Active Ingredient(s) (Active ingredient(s))

Fexofenadine HCl 180 mg

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxide (black iron oxide),

hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate,

microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel
Allergy Relief
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)

Ask A Doctor Before Use If (Ask a doctor before use if)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

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

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


Advanced Ingredient Data


Raw Label Data

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