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Fexofenadine hydrochloride by AvPAK

Medically reviewed on February 19, 2018

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 60mg
Labeler: AvPAK
NDC Code: 50268-315

Fexofenadine Hydrochloride Tablets USP

Active ingredient(in each tablet)

Fexofenadine HCl USP, 60 mg


Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper resporatory 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 aluminium or magnesium antacids
  • do not take with fruit juices (see directions)

Stop use and ask 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 overtake one 180 mg tablet with water once a day;
do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours;
do not take more than 2 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask 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 and light

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

Questions or comments?

 call 1-855-361-3993

Principal Display Panel

NDC 50268-315-15
                       
Fexofenadine Hydrochloride Tablets USP
Antihistamine
60 mg
50 Tablets (5 x 10) Unit Dose
5026831515

NDC 50268-315-15
                       
Fexofenadine Hydrochloride Tablets USP
Antihistamine
60 mg
50 Tablets (5 x 10) Unit Dose
5026831515

Drug Facts
Active ingredient Purpose
(in each tablet)
Fexofenadine HCl USP, 60 mg ............ Antihistamine
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

Drug Facts (continued)
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 care
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 take one 60 mg tablet with
12 years and over water every 12 hours; do not
take more than 2 tablets in
24 hours.
children under do not use
12 years of age
adults 65 years ask a doctor
of age and older
consumers with ask a doctor
kidney disease
Drug Facts (continued)
Other information
• Store between 20° and 25°C (68° and 77°F)
• Protect from excessive moisture and light
Inactive ingredients
anhydrous lactose, colloidal silicon dioxide, corn starch,
croscarmellose sodium, hypromellose, lactose
monohydrate, polyethylene glycol 400, pregelatinized
corn starch, red iron oxide, stearic acid, titanium
dioxide, and yellow iron oxide.
Questions? Call 1-855-361-3993

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. LM-2075 AV 07/17 (P)


                    





FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-315(NDC:58602-710)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
STARCH, CORN 
STEARIC ACID 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
POLYETHYLENE GLYCOL 400 
Product Characteristics
Colororange (peach) Scoreno score
ShapeCAPSULE (Bevel Edge,Bioconvex) Size12mm
FlavorImprint CodeE;42
Contains    
Packaging
#Item CodePackage Description
1NDC:50268-315-1550 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:50268-315-111 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20203908/02/2017
Labeler - AvPAK (832926666)

 
AvPAK

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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