Good sense allergy and congestion reliefnon drowsy 24 hour tablet, extended release

Active ingredients (in each tablet)

Loratadine 10 mg

Pseudoephedrine sulfate 240 mg

Purpose

Antihistamine

Nasal decongestant

Uses

  1. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  2. sneezing
  3. itchy, watery eyes
  4. runny nose
  5. itching of the nose or throat
  6. temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
  7. reduces swelling of nasal passages
  8. temporarily relieves sinus congestion and pressure
  9. temporarily restores freer breathing through the nose

Warnings

Do not use

  1. if you have ever had an allergic reaction to this product or any of its ingredients
  2. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons 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

  1. heart disease
  2. thyroid disease
  3. high blood pressure
  4. diabetes
  5. trouble urinating due to an enlarged prostate gland
  6. 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

  1. an allergic reaction to this product occurs. Seek medical help right away.
  2. symptoms do not improve within 7 days or are accompanied by a fever
  3. 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

  1. 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

  1. do not use if blister unit is broken or torn
  2. store between 20C to 25C (68F to 77F)
  3. protect from light and store in a dry place

Inactive ingredients

black iron oxide, candelilla wax powder, colloidal silicon dioxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, propylene glycol, sodium lauryl sulfate, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Good sense allergy and congestion reliefnon drowsy 24 hour tablet, extended release- Loratadine, pseudoephedrine sulfate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0113-1165
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Pseudoephedrine sulfate ( UNII: Y9DL7QPE6B)( Pseudoephedrine - UNII: 7CUC9DDI9F ) 240 mgin 1
Loratadine ( UNII: 7AJO3BO7QN)( Loratadine - UNII: 7AJO3BO7QN ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Ferrosoferric oxide ( UNII: XM0M87F357)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Glyceryl monostearate ( UNII: 230OU9XXE4)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Polyethylene glycol ( UNII: 3WJQ0SDW1A)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Candelilla wax ( UNII: WL0328HX19)
Propylene glycol ( UNII: 6DC9Q167V3)

Product Characteristics

Color WHITE (to off white) Size 18 mm
Shape OVAL Score 1
Imprint Code Andrx;605

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075706 USA

Labeler - L. Perrigo Company( 006013346)

Principal display panel

Non-Drowsy*

Original Prescription Strength

*When taken as directed. See Drug Facts Panel.

Allergy & Congestion Relief

Pseudoephedrine Sulfate 240 mg/Nasal Decongestant

Loratadine 10 mg/Antihistamine

Actual Size

Extended Release Tablets

24 Hour

Relief of: Nasal & Sinus Congestion Due to Colds or Allergies

Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose Due to Allergies

Compare to active ingredients of Claritin-D® 24 Hour Tablets

Allergy & Congestion Relief Carton Image 1 Allergy & Congestion Relief Carton Image 1

Allergy & Congestion Relief Carton Image 2