drug facts

drug facts
SPL v3
SPL
SPL Set ID d33f15db-0e5e-4515-b7a7-cb2760469ac1
Route
oral
Published
Effective Date 2024-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fexofenadine (180 mg)
Inactive Ingredients
ferrosoferric oxide croscarmellose sodium hypromelloses ferric oxide red ferric oxide yellow lactose monohydrate polyethylene glycol, unspecified titanium dioxide magnesium stearate starch, corn cellulose, microcrystalline silicon dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G6 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
anda active Since 2021-10-08

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg


Medication Information

Active Ingredient

Fexofenadine HCl USP, 180 mg

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
Purpose

Antihistamine

Directions
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
  • store between 20-25ºC (68-77ºF)
  • protect from excessive moisture
Inactive Ingredients

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

Description

Fexofenadine HCl USP, 180 mg

Principal Display Panel

*Compare to the active ingredient in Allegra® Allergy 24 Hour

Allergy Relief

Fexofenadine HCl Tablets, 180 mg

Antihistamine

24-Hour relief of

  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itchy nose or throat

For Indoor & outdoor allergies

Non-drowsy

Caplets**

(**Capsule-shaped tablets)

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 Hour.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Manufactured for FSA Stores Inc.

5473 BLAIR ROAD

SUITE 100

PMB 24308

DALLAS, TX 75231

Do Not Use

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

Product Label
Caring Mill - Allergy Relief Fexofenadine HCl Tablets, 180 mg
Questions Or Comments?

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

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.

Ask A Doctor Before Use If You Have

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


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Fexofenadine HCl USP, 180 mg

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
Purpose

Antihistamine

Directions
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 (Other information)
  • store between 20-25ºC (68-77ºF)
  • protect from excessive moisture
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

*Compare to the active ingredient in Allegra® Allergy 24 Hour

Allergy Relief

Fexofenadine HCl Tablets, 180 mg

Antihistamine

24-Hour relief of

  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itchy nose or throat

For Indoor & outdoor allergies

Non-drowsy

Caplets**

(**Capsule-shaped tablets)

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 Hour.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Manufactured for FSA Stores Inc.

5473 BLAIR ROAD

SUITE 100

PMB 24308

DALLAS, TX 75231

Do Not Use (Do not use)

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

Product Label
Caring Mill - Allergy Relief Fexofenadine HCl Tablets, 180 mg
Questions Or Comments? (Questions or comments?)

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

When Using This Product (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 (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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


Advanced Ingredient Data


Raw Label Data

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