ALLERGY AND CONGESTION RELIEF NON DROWSY- pseudoephedrine sulfate, loratadine tablet, film coated

allergy and congestion relief by

Drug Labeling and Warnings

allergy and congestion relief by is a Otc medication manufactured, distributed, or labeled by HyVee Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Loratadine 10 mg

Pseudoephedrine sulfate 240 mg

Purpose

Antihistamine

Nasal decongestant

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

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 & Congestion Relief Carton Image 1

Allergy & Congestion Relief Carton Image 2

INGREDIENTS AND APPEARANCE

ALLERGY AND CONGESTION RELIEF  NON DROWSY
pseudoephedrine sulfate, loratadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-724
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE SULFATE	240 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (Off-White)	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	L724
Contains

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

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

Labeler - HyVee Inc (006925671)