Valumeds Non-drowsy Allergy Relief, Fexofenadine Hcl

SPL v1

SPL

SPL Set ID f9ccd673-c65f-45c6-9863-26136eb816db

Route

ORAL

Published

Effective Date 2025-12-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (180 mg)

Inactive Ingredients

Silicon Dioxide Hypromellose, Unspecified Light Mineral Oil Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Ferric Oxide Red Sodium Starch Glycolate Type A Talc Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance

Imprint: j;44 Shape: capsule Color: pink Size: 18 mm Score: 1

Marketing Status

ANDA Active Since 2025-11-01

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 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

Drug Facts

Active Ingredient

Fexofenadine HCl USP, 180 mg

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, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide

Questions Or Comments?

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

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)

Packege Labeling: 82725 1202 2

Packege Labeling: 82725 1202 1

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 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

Drug Facts

Active Ingredient (Active ingredient)

Fexofenadine HCl USP, 180 mg

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)

Questions Or Comments? (Questions or comments?)

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

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)

Packege Labeling: 82725 1202 2 (Packege Labeling: 82725-1202-2)

Packege Labeling: 82725 1202 1 (Packege Labeling: 82725-1202-1)

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

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FEXOFENADINE", "unii": "E6582LOH6V", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

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 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", "Active ingredient": "Fexofenadine HCl USP, 180 mg", "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, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide", "Questions or comments?": "contact 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:07.016819 · Updated: 2026-03-14T23:12:15.627416