Label: 12 HOUR ALLERGY AND CONGESTION- loratadine, pseudoephedrine sulfate tablet, film coated, extended release
- NDC Code(s): 0363-1133-46, 0363-1133-60, 0363-1133-65
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each tablet)
- Purpose
-
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
- When using this product do not take more than directed.
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Package/Label Principal Display Panel
NON-DROWSY*
Wal-itin® D
Compare to Claritin-D® 12 Hour Tablets active ingredients
12 HOUR ALLERGY & CONGESTION
PSEUDOEPHEDRINE SULFATE 120 mg / NASAL DECONGESTANT
LORATADINE 5 mg / ANTIHISTAMINE
EXTENDED-RELEASE TABLETS
12 HOUR - EXTENDED RELEASE TABLETS
INDOOR & OUTDOOR ALLERGIES
12-hour relief of: nasal & sinus congestion due to colds or allergies; sneezing; runny nose; itchy, watery eyes & itchy throat or nose due to allergies
30 EXTENDED-RELEASE TABLETS
*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.
12 HOUR
ACTUAL SIZE
-
INGREDIENTS AND APPEARANCE
12 HOUR ALLERGY AND CONGESTION
loratadine, pseudoephedrine sulfate tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1133 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 5 mg PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 120 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (to off-white) Score no score Shape ROUND Size 12mm Flavor Imprint Code 7U0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1133-46 10 in 1 CARTON 05/05/2018 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0363-1133-60 20 in 1 CARTON 05/05/2018 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0363-1133-65 30 in 1 CARTON 05/05/2018 3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076050 05/05/2018 Labeler - Walgreen Company (008965063)