Childrens Allergy Relief: Package Insert and Label Information

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

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 over take 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?

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*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
(click image for full-size original)

CHILDRENS ALLERGY RELIEF

CHILDRENS ALLERGY RELIEF
fexofenadine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63548-0662
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LIGHT MINERAL OIL
HYPROMELLOSES
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TALC
TITANIUM DIOXIDE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 6mm
Flavor Imprint Code J;42
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63548-0662-5 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204097 10/01/2019
Labeler — PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 07/2019 PLD Acquisitions LLC DBA Avéma Pharma Solutions

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