b7e9477d-33d9-4463-b8a6-69af5f71ce35
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg
Purpose
Antihistamine
Medication Information
Indications and Usage
Uses
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Purpose
Antihistamine
Description
Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg
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
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
Severe Allergy Warning:Get emergency help immediatelyif you have hives along with any of the following symptoms:
- trouble swallowing
- dizziness or loss of consciousness
- swelling of tongue
- swelling in or around mouth
- trouble speaking
- drooling
- wheezing or problems breathing
These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health profession immediately.Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine.If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.
Section 51945-4
Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA
Section 53414-9
If pregnant or breast-feeding,
ask a health professional before use.
Do Not Use
to preventhives from any known cause such as:
- foods
- insect stings
- medicines
- latex or rubber gloves
because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
•If you have ever had an allergic reaction to this product or any of its ingredients
Hives
Fexofenadine HCl USP 60 mg
Fexofenadine HCl USP 180 mg
Other Information
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
- each tablet contains:sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
- this product meets the requirements of USP Dissolution Test 2
- Tamper Evident:Do not use if imprinted inner safety seal is torn or missing
Inactive Ingredients
anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.
Directions (for 60mg)
|
adults and children 12 years of age and over |
take one 60mg tablet with water every 12 hours; do not take more than 2 tablets 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 |
Directions (for 180mg)
|
adults and children 12 years of age and over |
take one 180mg 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 |
Questions Or Comments?
Call toll-free 1-855-724-3436
Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA
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.
- symptoms do not improve after 3 days of treatment
- the hives have lasted more than 6 weeks
Ask A Doctor Before Use If You Have
- kidney disease.Your doctor should determine if you need a different dose.
- hives that are an unusual color, look bruised or blistered
- hives that do not itch
Package/label Principal Display Panel
Fexofenadine Hydrochloride Tablets USP 60mg
Allergy
Fexofenadine HCl USP 60 mg
Fexofenadine HCl USP 180 mg
Structured Label Content
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
Indications and Usage (34067-9)
Uses
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
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)
Severe Allergy Warning:Get emergency help immediatelyif you have hives along with any of the following symptoms:
- trouble swallowing
- dizziness or loss of consciousness
- swelling of tongue
- swelling in or around mouth
- trouble speaking
- drooling
- wheezing or problems breathing
These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health profession immediately.Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine.If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.
Section 51945-4 (51945-4)
Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA
Section 53414-9 (53414-9)
If pregnant or breast-feeding,
ask a health professional before use.
Purpose
Antihistamine
Do Not Use (Do not use)
to preventhives from any known cause such as:
- foods
- insect stings
- medicines
- latex or rubber gloves
because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
•If you have ever had an allergic reaction to this product or any of its ingredients
Hives ( HIVES)
Fexofenadine HCl USP 60 mg
Fexofenadine HCl USP 180 mg
Other Information (Other information)
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
- each tablet contains:sodium 2.7mg(for 60 mg), sodium 8.2mg(for 180 mg)
- this product meets the requirements of USP Dissolution Test 2
- Tamper Evident:Do not use if imprinted inner safety seal is torn or missing
Inactive Ingredients (Inactive ingredients)
anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.
Directions (for 60mg)
|
adults and children 12 years of age and over |
take one 60mg tablet with water every 12 hours; do not take more than 2 tablets 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 |
Directions (for 180mg)
|
adults and children 12 years of age and over |
take one 180mg 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 |
Questions Or Comments? (Questions or comments?)
Call toll-free 1-855-724-3436
Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA
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.
- symptoms do not improve after 3 days of treatment
- the hives have lasted more than 6 weeks
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.
- hives that are an unusual color, look bruised or blistered
- hives that do not itch
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Fexofenadine Hydrochloride Tablets USP 60mg
Allergy ( ALLERGY)
Fexofenadine HCl USP 60 mg
Fexofenadine HCl USP 180 mg
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:03.345628 · Updated: 2026-03-14T23:06:22.021295