Valumeds 24-hour Allergy Relief Fexofenadine

SPL v3

SPL

SPL Set ID 036f8eaa-7eb9-46f4-b42e-3c8c7e49e450

Route

ORAL

Published

Effective Date 2025-10-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Hypromellose, Unspecified Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Lactose Monohydrate Polyethylene Glycol, Unspecified Magnesium Stearate Microcrystalline Cellulose Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: G6 Shape: capsule Color: pink Size: 17 mm Score: 1

Marketing Status

ANDA Active Since 2024-11-01

Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 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

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 6 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

Drug Facts

Questions?

call 1-908-242-6108Mon-Fri 8:00 AM to 5:00 PM EST

Other Information

safety sealed: do not use if imprinted foil under bottle cap is opened or torn
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide

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.

Package Labeling: 82725 1002 2

Package Labeling: 82725 1002 3

Package Labeling: 82725 1002 1

Active Ingredient (in Each Tablet)

Fexofenadine HCl USP, 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
itchy, watery eyes
sneezing
itching of the nose or throat

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 6 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

Drug Facts

Questions?

call 1-908-242-6108Mon-Fri 8:00 AM to 5:00 PM EST

Other Information (Other information)

safety sealed: do not use if imprinted foil under bottle cap is opened or torn
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

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.

Package Labeling: 82725 1002 2 (Package Labeling: 82725-1002-2)

Package Labeling: 82725 1002 3 (Package Labeling: 82725-1002-3)

Package Labeling: 82725 1002 1 (Package Labeling: 82725-1002-1)

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

Fexofenadine HCl USP, 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

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Raw Label Data

All Sections (JSON)

{"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 6 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 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST", "Other information": "safety sealed: do not use if imprinted foil under bottle cap is opened or torn store between 20° and 25°C (68° and 77°F) protect from excessive moisture", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide", "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.", "Active ingredient (in each tablet)": "Fexofenadine HCl USP, 180 mg", "Ask a doctor before use if you have": "kidney disease. Your doctor should determine if you need a different dose."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:12.250222 · Updated: 2026-03-14T23:13:07.898715