Loratadine and pseudoephedrine tablet, extended release

Active ingredients (in each tablet)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 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
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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 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

  • 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 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

  • sodium: contains 10 mg/tablet
  • calcium: contains 25 mg/tablet
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20 C to 25 C (68 F to 77 F)
  • protect from light and store in a dry place

Inactive ingredients

Calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

Questions?

Call 1-800-406-7984

Ingredients and appearance - Product information

Loratadine and pseudoephedrine tablet, extended release- Loratadine and pseudoephedrine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 63187-305
Route of Administration Oral

Active Ingredient/Active Moiety

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

Inactive Ingredients

Ingredient Name Code
Calcium carbonate ( UNII: H0G9379FGK)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hydroxypropyl cellulose (1600000 wamw) ( UNII: RFW2ET671P)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone, unspecified ( UNII: FZ989GH94E)
Starch, corn ( UNII: O8232NY3SJ)
Propylene glycol ( UNII: 6DC9Q167V3)
Shellac ( UNII: 46N107B71O)
Sodium alginate ( UNII: C269C4G2ZQ)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferrosoferric oxide ( UNII: XM0M87F357)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)

Product Characteristics

Color white Size 17 mm
Shape CAPSULE Score 1
Imprint Code RX724

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076557 USA

Labeler - Proficient Rx LP( 079196022)

Establishment

Name ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK( 63187-305), RELABEL( 63187-305)

Principal display panel

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

ohm ®

NDC 63187-305-10

NON-DROWSY *

24 Hour Allergy Relief

Original Prescription Strength

Allergy Relief & Nasal Decongestant

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Relief of:

  • Nasal & Sinus Congestion Due to Colds or Allergies
  • Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose Due to Allergies

Allergy & Congestion

5 Extended-Release Tablets

*When taken as directed. See Drug Facts Panel.

Distributed by: Ohm Laboratories Inc.

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

5079399/R0610

5s blister carton

5s blister carton