Label: WAL ITIN D NON DROWSY- pseudoephedrine sulfate and loratadine 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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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 DEA Schedule 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)