437 - Allergy Relief - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (60 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: G5 Shape: oval Color: pink Size: 12 mm Score: 1

Marketing Status

ANDA Active Since 2022-05-18

Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl 60mg

Use(s)

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

Questions

Questions or comments?

Call 1-888-952-0050

Monday through Friday 9AM - 5PM

Directions

Adults and children 12 years of age and over: take one 60 mg caplet with water every 12 hours; do not take more than 2 caplets 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

Other Information

store at room temperature 20°– 25°C (68°– 77°F)

protect from excessive moisture

do not use if imprinted seal under safety cap is broken or missing

Active Ingredient(s)

Fexofenadine HCl 60mg

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron

oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene

glycol, pregelatinized starch, purified water, titanium dioxide

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Allergy Relief

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)

Ask A Doctor Before Use If

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

Stop Use and Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Structured Label Content

Use(s)

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

Questions

Questions or comments?

Call 1-888-952-0050

Monday through Friday 9AM - 5PM

Directions

Adults and children 12 years of age and over: take one 60 mg caplet with water every 12 hours; do not take more than 2 caplets 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

Other Information (Other information)

store at room temperature 20°– 25°C (68°– 77°F)

protect from excessive moisture

do not use if imprinted seal under safety cap is broken or missing

Active Ingredient(s) (Active ingredient(s))

Fexofenadine HCl 60mg

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron

oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene

glycol, pregelatinized starch, purified water, titanium dioxide

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Allergy Relief

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)

Ask A Doctor Before Use If (Ask a doctor before use if)

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

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.

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Advanced Ingredient Data

[{"name": "FEXOFENADINE", "unii": "E6582LOH6V", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "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", "Questions": "Questions or comments? Call 1-888-952-0050 Monday through Friday 9AM - 5PM", "Directions": "Adults and children 12 years of age and over: take one 60 mg caplet with water every 12 hours; do not take more than 2 caplets 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 diseas e: ask a doctor", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients", "Other information": " store at room temperature 20°– 25°C (68°– 77°F) protect from excessive moisture do not use if imprinted seal under safety cap is broken or missing", "Active ingredient(s)": "Fexofenadine HCl 60mg", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water, titanium dioxide", "Pregnancy/Breastfeeding": "ask a health professional before use.", "Principal Display Panel": "Allergy Relief", "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)", "Ask a doctor before use if": "you have kidney disease. Your doctor should determine if you need a different dose.", "Stop use and ask a doctor if": "an allergic reaction to this product occurs. Seek medical help right away.", "Keep out of reach of children": "In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away."}

437 - Allergy Relief

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information