Fexofenadine Hcl Usp 180mg

Fexofenadine Hcl Usp 180mg
SPL v2
SPL
SPL Set ID 9717c35e-cfd3-6605-e053-2995a90a1de5
Route
ORAL
Published
Effective Date 2019-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Hypromellose, Unspecified Titanium Dioxide Polyethylene Glycol 6000 Ferric Oxide Red Stearic Acid Starch, Corn Silicon Dioxide Ferric Oxide Yellow Anhydrous Lactose Croscarmellose

Identifiers & Packaging

Pill Appearance
Imprint: SG;202 Shape: capsule Color: pink Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2019-07-22

Description

Fexofenadine HCl USP 180 mg


Medication Information

Warnings and Precautions

Do not use

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

Ask a doctor before use if you have

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

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

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

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Indications and Usage

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Dosage and Administration
  • adults & 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
Description

Fexofenadine HCl USP 180 mg

Section 50565-1

Keep out of reach of children

Overdose Warning: Taking more than directed can cause serious health problems. Incase of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregalatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, yellow iron oxide

Section 51945-4

Section 55105-1

Antihistamine

Section 55106-9

Fexofenadine HCl USP 180 mg

Section 60561-8
  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
  • protect from excessive moisture
  • each tablet contains: sodium 8.2 mg
  • this product meets the requirements of USP Dissolution Test 2

Tamper Evident: Do not use if package is opened or if blister unite is torn broken or shows any signs of tampering.


Structured Label Content

Indications and Usage (34067-9)

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Dosage and Administration (34068-7)
  • adults & 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
Warnings and Precautions (34071-1)

Do not use

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

Ask a doctor before use if you have

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

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

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

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children

Overdose Warning: Taking more than directed can cause serious health problems. Incase of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregalatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, yellow iron oxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Fexofenadine HCl USP 180 mg

Section 60561-8 (60561-8)
  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
  • protect from excessive moisture
  • each tablet contains: sodium 8.2 mg
  • this product meets the requirements of USP Dissolution Test 2

Tamper Evident: Do not use if package is opened or if blister unite is torn broken or shows any signs of tampering.


Advanced Ingredient Data


Raw Label Data

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