Label: WAL ITIN D NON DROWSY- loratadine, pseudoephedrine sulfate tablet, extended release
- NDC Code(s): 0363-0165-13, 0363-0165-22, 0363-0165-52
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 5, 2009
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- Active ingredient (in each tablet)
Loratadine 10 mg
Pseudoephedrine sulfate 240 mgClose
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- 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
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
- 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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- do not use if blister unit is broken or torn
- store between 20º to 25ºC (68º to 77ºF)
- 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 dioxideClose
- Questions or comments?
- Principal Display Panel
Compare to Claritin-D® 24 Hour active ingredients
Pseudoephedrine Sulfate 240 mg/Nasal Decongestant
Loratadine 10 mg/Antihistamine
Allergy & Congestion Relief
Relief of: Nasal & Sinus Congestion due to Colds or Allergies
Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose due to Allergies
*When taken as directed. See Drug Facts Panel.
Wal-itin D Carton Image 1
Wal-itin D Carton Image 2
- INGREDIENTS AND APPEARANCE
WAL ITIN D NON DROWSY
loratadine, pseudoephedrine sulfate tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0165 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 240 mg LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) CANDELILLA WAX (UNII: WL0328HX19) 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) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (to off white) Score no score Shape OVAL Size 18mm Flavor Imprint Code Andrx;605 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0165-13 1 in 1 CARTON 1 5 in 1 BLISTER PACK 2 NDC:0363-0165-52 2 in 1 CARTON 2 5 in 1 BLISTER PACK 3 NDC:0363-0165-22 3 in 1 CARTON 3 5 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075706 06/04/2003 Labeler - Walgreen Company (008965063)