CHILDRENS ALLERGY RELIEF- fexofenadine hcl tablet 
PLD Acquisitions LLC DBA Avéma Pharma Solutions

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DRUG FACTS

Active ingredient (in each tablet)

Fexofenadine HCL USP 30 mg

Purpose

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

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 (1-800-222-1222).

Directions

adults and children 12 years of age and overtake two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours 
children 6 to under 12 years of age  take one tablet with water every 12 hours; do not take more than 2 tablets in 24 hours 
children under 6 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

  • Tamper Evident: do not use if printed safety seal under cap is broken or missing
  • store between 20º and 25ºC (68º and 77ºF)
  • 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, yellow iron oxide

Questions or comments?


Principal Display Panel

*Compare to the active ingredient in Children's Allegra® Allergy 12 Hour

Children's Allergy Relief

Fexofenadine HCL USP 30 mg

Antihistamine

24 Hour Relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy nose or throat

Indoor and outdoor allergy relief

Non-drowsy

Tablets

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 12 hour.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.


Product Label

Fexofenadine HCL USP 30 mg

CHILDRENS ALLERGY RELIEF

CHILDRENS ALLERGY RELIEF 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0662
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize6mm
FlavorImprint Code J;42
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-0662-5500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20409710/01/2019
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 2/2023
Document Id: 82398f8d-edba-4d93-bbd9-e9f40e42693b
Set id: 052d6191-1d9c-45c9-8c81-d19a977eded5
Version: 5
Effective Time: 20230209
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions