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Allergy and congestion relief by Kroger Company

Medically reviewed on January 15, 2018

Dosage form: tablet, extended release
Ingredients: LORATADINE 5mg, PSEUDOEPHEDRINE SULFATE 120mg
Labeler: Kroger Company
NDC Code: 30142-013

Kroger Co. Allergy & Congestion Relief Drug Facts

Active ingredients (in each tablet)

Loratadine 5 mg

Pseudoephedrine sulfate 120 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. (1-800-222-1222)

Directions
do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over

1 tablet every 12 hours; not more than 2 tablets in 24 hours

children under 12 years of age

ask a doctor

consumers with liver or

kidney disease

ask a doctor

Other information
each tablet contains: calcium 25 mg
do not use if blister unit is broken or torn
store between 20° to 25°C (68° to 77°F)
keep in a dry place

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

Questions or comments?

1-800-632-6900

Package/Label Principal Display Panel

COMPARE TO the active ingredients of CLARITIN-D® 12 HOUR

See bottom panel

ORIGINAL PRESCRIPTION STRENGTH

NON-DROWSY*

Allergy & Congestion Relief

12 HOUR

*When taken as directed.

See Drug Facts Panel.

Pseudoephedrine Sulfate 120 mg/Nasal Decongestant

Loratadine 5 mg/Antihistamine

EXTENDED RELEASE TABLETS

Indoor & Outdoor Allergies

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing – Runny Nose – Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

30 EXTENDED RELEASE TABLETS

actual size

ALLERGY AND CONGESTION RELIEF 
loratadine, pseudoephedrine tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-013
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE5 mg
PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE120 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POVIDONES 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:30142-013-3930 BLISTER PACK in 1 CARTON
11 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07605004/06/2012
Labeler - Kroger Company (006999528)

 
Kroger Company

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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