Fexofenadine hcl tablet

Active ingredient(s), in each tablet

Fexofenadine hydrochloride USP, 180 mg

Purpose

Antihistamine

Use(s)

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


Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.


Ask a doctor before use if

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

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.

Directions

60 mg


adults and children 12 years of age and over
take one 60 mg 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


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







Other information

  • Safety Sealed: do not use if carton is opened or if printed foil inner seal on the bottle is torn or missing.
  • store between 20 and 25C (68 and 77F)
  • 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 and yellow iron oxide.

Questionsor comments

call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418

Ingredients and appearance - Product information

Fexofenadine hcl tablet- Fexofenadine hcl

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 69230-300
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Fexofenadine hydrochloride ( UNII: 2S068B75ZU)( Fexofenadine - UNII: E6582LOH6V ) 180 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hypromellose 2910 (6 mpa.s) ( UNII: 0WZ8WG20P6)
Light mineral oil ( UNII: N6K5787QVP)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Starch, corn ( UNII: O8232NY3SJ)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyethylene glycol 6000 ( UNII: 30IQX730WE)

Product Characteristics

Color PINK Shape CAPSULE
Size 18 mm Score 1
Imprint Code J;44

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA204097 USA

Fexofenadine hcl tablet- Fexofenadine hcl

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 69230-301
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Fexofenadine hydrochloride ( UNII: 2S068B75ZU)( Fexofenadine - UNII: E6582LOH6V ) 60 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Light mineral oil ( UNII: N6K5787QVP)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Hypromellose 2910 (6 mpa.s) ( UNII: 0WZ8WG20P6)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Starch, corn ( UNII: O8232NY3SJ)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyethylene glycol 6000 ( UNII: 30IQX730WE)

Product Characteristics

Color PINK Shape OVAL
Size 12 mm Score 1
Imprint Code J;43

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA204097 USA

Labeler - Camber Consumer Care( 079539968)

Establishment

Name ID/FEI Business Operations
Camber Consumer Care 079539968 ANALYSIS( 69230-300, 69230-301), MANUFACTURE( 69230-300, 69230-301)

Principal display panel

Fexofenadine Hydrochloride Tablets, USP 180 mg 30s Container Label



Fexofenadine Hydrochloride Tablets, USP 180 mg 30s Carton Label



Fexofenadine Hydrochloride Tablets, USP 180 mg 100s Container Label



Fexofenadine Hydrochloride Tablets, USP 180 mg 100s Carton Label



Fexofenadine Hydrochloride Tablets, USP 180 mg 500s Container Label