Magno-humphries - Antihistamine Allergy Relief

Magno-humphries - Antihistamine Allergy Relief
SPL v4
SPL
SPL Set ID 1f8a2f98-7eba-48df-9589-58587d67ae0e
Route
ORAL
Published
Effective Date 2021-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: SG202 Shape: capsule Color: pink Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2021-03-25

Description

Fexofenadine HCl 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl 180 mg

Uses

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
Section 51945-4

Warnings

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.

Questions?

call toll-free 1-800-935-6737

Other Information
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains: sodium 8.2 mg
  • this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients

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

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 (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Fexofenadine HCl 180 mg

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
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Section 51945-4 (51945-4)

Purpose

Antihistamine

Warnings

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.

Questions?

call toll-free 1-800-935-6737

Other Information (Other information)
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains: sodium 8.2 mg
  • 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, polyethylene glycol,  pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, yellow iron oxide.

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 (1-800-222-1222) right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCl 180 mg

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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