ALLERGY RELIEF- fexofenadine hcl tablet 
Allwell Health Inc

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DRUG FACTS

Active ingredient (in each tablet)

Fexofenadine HCl USP 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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 (1-800-222-1222) 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

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, polyethylene glycol, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

allergy relief

fexofenadine HCI tablets USP 180 mg

antihistamine

24 hour relief of

non-drowsy

caplets**

(**capsule-shaped tablets)

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

distributed by:

AllWell Health, Inc.

Princeton, NJ 08540

getallwell.com

Product Label

Fexofenadine HCl USP, 180 mg

ALLWELL Allergy Relief

ALLERGY RELIEF 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80539-801
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code G6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80539-801-301 in 1 BOX01/29/2021
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21107501/29/2021
Labeler - Allwell Health Inc (117644800)

Revised: 9/2021
Document Id: 30c8af78-3c92-4205-9f0a-724c092dbfc0
Set id: 039276e6-54bd-47a2-be85-ed967c645d45
Version: 1
Effective Time: 20210930
 
Allwell Health Inc