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Fexofenadine HCl by Proficient Rx LP

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 180mg
Labeler: Proficient Rx LP
NDC Code: 63187-921

FEXOFENADINE HYDROCHLORIDE TABLETS USP, 180 mg
Allergy


ALLERGY
Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

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

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

 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

Other information
safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
each tablet contains: sodium 8.2 mg
this product meets the requirements of USP Dissolution Test 2

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.

Questions or comments?

Call 1-888-588-1418

Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA,

Repackaged by:
Proficient Rx LP.
Thousand Oaks, CA 91320

Made in USA

Compare to the active ingredient in Allegra® Allergy 24 Hour Tablets
Allergy Relief - 24 HOUR
FEXOFENADINE HYDROCHLORIDE TABLETS USP, 180 mg
Antihistamine
Indoor & Outdoor Allergies
FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-921(NDC:69230-202)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
LACTOSE MONOHYDRATE 
STEARIC ACID 
HYPROMELLOSE, UNSPECIFIED 
POLYETHYLENE GLYCOL, UNSPECIFIED 
FERRIC OXIDE RED 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize17mm
FlavorImprint CodeSG;202
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-921-2020 TABLET, FILM COATED in 1 BOTTLE
2NDC:63187-921-3030 TABLET, FILM COATED in 1 BOTTLE
3NDC:63187-921-6060 TABLET, FILM COATED in 1 BOTTLE
4NDC:63187-921-9090 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450709/16/2015
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-921), RELABEL(63187-921)

 
Proficient Rx LP

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Medically reviewed on Oct 2, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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