Curist Allergy Relief (fexofenadine Hcl 180 Mg)

Curist Allergy Relief (fexofenadine Hcl 180 Mg)
SPL v4
SPL
SPL Set ID f8228938-b5e3-0fa8-e053-6294a90a1d7c
Route
ORAL
Published
Effective Date 2024-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: SG;202 Shape: capsule Color: pink Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2023-03-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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
Dosage and Administration

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • each tablet contains: sodium 8.2 mg
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2
  • Tamper Evident: Do not use if imprinted inner safety seal is torn or missing.
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

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)
Section 50569-3

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 51727-6

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, opadry pink 03B84893 containing hypromellose, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, yellow iron oxide.

Section 51945-4

curist

Allergy Relief

Fexofenadine Hydrochloride

Tablets, USP 180 mg

Antihistamine

24 Hour Reilef of Runny Nose; Sneezing;

Itchy, Watery Eyes; Itchy Nose or Throat

Indoor and Outdoor Allergies

Non-Drowsy

200 Tablets

Section 53413-1

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP 180 mg


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • each tablet contains: sodium 8.2 mg
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2
  • Tamper Evident: Do not use if imprinted inner safety seal is torn or missing.
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

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)
Section 50569-3 (50569-3)

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, opadry pink 03B84893 containing hypromellose, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, yellow iron oxide.

Section 51945-4 (51945-4)

curist

Allergy Relief

Fexofenadine Hydrochloride

Tablets, USP 180 mg

Antihistamine

24 Hour Reilef of Runny Nose; Sneezing;

Itchy, Watery Eyes; Itchy Nose or Throat

Indoor and Outdoor Allergies

Non-Drowsy

200 Tablets

Section 53413-1 (53413-1)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP 180 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)