Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 04abc65c-6967-47df-84b1-4f28fbaa3a68
Route
ORAL
Published
Effective Date 2022-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Hypromelloses Ferric Oxide Red Ferric Oxide Yellow Magnesium Stearate Polyethylene Glycol, Unspecified Titanium Dioxide Microcrystalline Cellulose Starch, Corn Polysorbate 80 Sodium Starch Glycolate Type A Corn Talc

Identifiers & Packaging

Pill Appearance
Imprint: J;44 Shape: capsule Color: pink Size: 18 mm Score: 1
Marketing Status
ANDA Active Since 2019-10-01

Description

Fexofenadine HCL USP 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

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
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
Do Not Use

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

Product Label
WELLNESS BASICS Allergy Relief
Other Information
  • safety sealed: do not use if printed safety seal under cap is missing or broken or if individual blisted units are torn or opened
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture



Inactive Ingredients

colloidal silicon dioxide, hypromellose, 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?

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

Principal Display Panel

allergy relief

Fexofenadine HCL USP 180 mg tablets

antihistamine

  • for indoor and outdoor allergies
  • non-drowsy

caplets**

(**capsule-shaped tablets)

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

*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.

Distributed by: PL Developments

200 Hicks Street Westbury, NY 11590

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).

Active Ingredient (in Each Tablet)

Fexofenadine HCL USP 180 mg

Ask A Doctor Before Use If You Have

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


Structured Label Content

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
Do Not Use (Do not use)

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

Product Label
WELLNESS BASICS Allergy Relief
Other Information (Other information)
  • safety sealed: do not use if printed safety seal under cap is missing or broken or if individual blisted units are torn or opened
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture



Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, 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? (Questions or comments?)

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

Principal Display Panel

allergy relief

Fexofenadine HCL USP 180 mg tablets

antihistamine

  • for indoor and outdoor allergies
  • non-drowsy

caplets**

(**capsule-shaped tablets)

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

*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.

Distributed by: PL Developments

200 Hicks Street Westbury, NY 11590

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 right away (1-800-222-1222).

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCL USP 180 mg

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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