topco associates llc. allergy relief drug facts

topco associates llc. allergy relief drug facts
SPL v3
SPL
SPL Set ID e7658b5f-2d78-4f25-b1a3-e49198ca8f32
Route
oral
Published
Effective Date 2025-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fexofenadine (180 mg)
Inactive Ingredients
croscarmellose sodium fd&c blue no. 2 fd&c red no. 40 fd&c yellow no. 6 lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L847 Shape: oval Color: pink Size: 18 mm Score: 1
Marketing Status
anda completed Since 2021-08-23 Until 2023-12-31

Purpose

Antihistamine

Description

Fexofenadine HCl 180 mg


Medication Information

Active Ingredient

Fexofenadine HCl 180 mg

Uses

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

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

Other Information
  • do not use if printed blister unit is broken or torn
  • store between 20° -25°C (68° -77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Description

Fexofenadine HCl 180 mg

Do Not Use

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

Questions Or Comments?

1-888-423-0139

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 right away (1-800-222-1222).

Ask A Doctor Before Use If You Have

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

Package/label Principal Display Panel

COMPARE TO ALLEGRA® ALLERGY ACTIVE INGREDIENT

NON-DROWSY

Allergy Relief

FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg (ANTIHISTAMINE)

24 HR

INDOOR/OUTDOOR ALLERGY RELIEF

- Sneezing – Runny Nose

- Itchy, Watery Eyes

- Itchy Nose or Throat

5 TABLETS

actual size


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Fexofenadine HCl 180 mg

Uses

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

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

Other Information (Other information)
  • do not use if printed blister unit is broken or torn
  • store between 20° -25°C (68° -77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Do Not Use (Do not use)

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

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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 right away (1-800-222-1222).

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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

COMPARE TO ALLEGRA® ALLERGY ACTIVE INGREDIENT

NON-DROWSY

Allergy Relief

FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg (ANTIHISTAMINE)

24 HR

INDOOR/OUTDOOR ALLERGY RELIEF

- Sneezing – Runny Nose

- Itchy, Watery Eyes

- Itchy Nose or Throat

5 TABLETS

actual size


Advanced Ingredient Data


Raw Label Data

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