450 - Allergy Relief

450 - Allergy Relief
SPL v4
SPL
SPL Set ID 89ece1b5-7604-4dce-a8a6-df5b948e3cff
Route
ORAL
Published
Effective Date 2024-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Starch, Corn Ferric Oxide Red Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide Ferric Oxide Yellow Light Mineral Oil

Identifiers & Packaging

Pill Appearance
Imprint: 44;J Shape: capsule Color: pink Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2024-04-17

Description

Fexofenadine hydrochloride USP, 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine hydrochloride USP, 180 mg

Use(s)

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: take one 180 mg caplet with water, once a and over 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
  • store at room temperature 20°– 25°C (68°– 77°F)
  • protect from excessive moisture
  • do not use if imprinted seal under safety cap is broken or missing
Questions/comments

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

Active Ingredient(s)

Fexofenadine hydrochloride USP, 180 mg

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
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

you have 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.

If Pregnant Or Breastfeeding,

ask a health professional before use.

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
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Purpose

Antihistamine

Directions

Adults and children 12 years of age: take one 180 mg caplet with water, once a and over 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)
  • store at room temperature 20°– 25°C (68°– 77°F)
  • protect from excessive moisture
  • do not use if imprinted seal under safety cap is broken or missing
Questions/comments (Questions/Comments)

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

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

Fexofenadine hydrochloride USP, 180 mg

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
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)

you have 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.

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

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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