Active Ingredient (In Each Tablet)
For 180 mg:
Fexofenadine HCl, USP 180 mg
The following Structured Product Label (SPL) was submitted to the FDA by Sun Pharmaceutical Industries, Inc. for the product Fexofenadine Hydrochloride (NDC 62756-545). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
For 180 mg:
Fexofenadine HCl, USP 180 mg
Antihistamine
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:
These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional 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.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
For 180 mg:
| 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 |
croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide
Call toll free 1-800-818-4555 weekdays.
For 180 mg : Label
NDC 62756-545-15
Fexofenadine Hydrochloride Tablets, USP
180 mg
HIVES
(24 Hour)
Reduces HIVES and Relieves ITCHING due to hives
Antihistamine
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
30 Tablets
180 mg each
Actual Size
For 180 mg : Carton
NDC 62756-545-15
Fexofenadine Hydrochloride Tablets, USP
180 mg
HIVES
(24 Hour)
Reduces HIVES and Relieves ITCHING due to hives
Antihistamine
NON-DROWSY
30 Tablets
180 mg each
Actual Size
For 180 mg : Blister Pack
NDC 62756-545-15
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine Hydrochloride Tablets, USP
180 mg
HIVES
(24 Hour)
Reduces HIVES and Relieves ITCHING due to hives
Antihistamine
5 (1 x 5) Tablets
180 mg each
Actual Size
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
For 180 mg : Blister Foil
Fexofenadine Hydrochloride Tablets, USP
24 Hour
180 mg
HIVES
Antihistamine
Mfg. by: Sun Pharmaceutical Ind. Ltd., India.
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