Perrigo Loratadine-D Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

LORATADINE D- loratadine, pseudoephedrine tablet, extended release 
Perrigo New York Inc

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Perrigo Loratadine-D 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?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Claritin-D® 12 Hour active ingredients

Loratadine-D

12 Hour

Pseudoephedrine Sulfate 120 mg / Loratadine 5 mg

Extended Release Tablets

Nasal Decongestant / Antihistamine

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

Indoor & Outdoor Allergies

Original Prescription Strength

actual size

Non-Drowsy*

*When taken as directed.

See Drug Facts Panel.

12 Hour Allergy & Congestion

10 Tablets

Perrigo Loratadine-D image
LORATADINE D 
loratadine, pseudoephedrine tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 45802-106
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE120 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 45802-106-5210 in 1 CARTON01/24/201208/31/2019
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 45802-106-6020 in 1 CARTON01/24/201208/31/2019
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 45802-106-3930 in 1 CARTON01/19/201208/31/2019
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07605001/19/201208/31/2019
Labeler - Perrigo New York Inc (078846912)

Revised: 9/2019
 
Perrigo New York Inc