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allergy and congestion relief

HyVee Inc

Hy-Vee, Inc. Allergy & Congestion Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Loratadine 10 mg

Pseudoephedrine sulfate 240 mg

Purpose

Antihistamine

Nasal decongestant

allergy and congestion relief Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itchy, watery eyes
  • runny nose
  • itching of the nose or throat
  • temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose

Warnings

Do not use

  • if you have ever had an allergic reaction to this product or any of its ingredients
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

  • an allergic reaction to this product occurs. Seek medical help right away.
  • symptoms do not improve within 7 days or are accompanied by a fever
  • nervousness, dizziness or sleeplessness occurs

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.

Directions

  • do not divide, crush, chew or dissolve the tablet
adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

allergy and congestion relief Other information

  • store between 20ºC to 25ºC (68ºF to 77ºF)
  • protect from light and store in a dry place

Inactive ingredients

colloidal silicon dioxide, hydrogenated vegetable oil, hypromellose, magnesium stearate, pharmaceutical ink, polyethylene glycol, polyethylene oxide, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Non-Drowsy

Compare to Claritin-D® 24 Hour active ingredients

Allergy & Congestion Relief

Pseudoephedrine Sulfate 240 mg/Nasal Decongestant

Loratadine 10 mg/Antihistamine

Extended Release Tablets

24 hour

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

Actual Size

Original Prescription Strength

*When taken as directed. See Drug Facts Panel.

allergy and congestion relief
Allergy & Congestion Relief Carton Image 1 Allergy & Congestion Relief Carton Image 2

allergy and congestion relief

Pseudoephedrine sulfate, Loratadine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42507-724
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg
PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE 240 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POLYETHYLENE GLYCOLS
titanium dioxide
SILICON DIOXIDE

Product Characteristics

Color Size Imprint Code Shape
WHITE (Off-White) 18 mm L724 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BLISTER PACK
2 NDC:42507-724-22 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075989 2010-10-26


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Be sure to consult your doctor before taking any medication!
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