NDC | 21130-007-60 |
Set ID | ccf60557-4463-4111-8e33-0511f42697a0 |
Category | HUMAN OTC DRUG LABEL |
Packager | Safeway |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | ANDA076050 |
- Active ingredients (in each tablet)
- Purpose
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Uses
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- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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- sneezing
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- itchy, watery eyes
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- runny nose
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- itching of the nose or throat
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- 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
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- temporarily restores freer breathing through the nose
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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
- •
- heart disease
- •
- thyroid disease
- •
- high blood pressure
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- 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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
12 HOUR | ORIGINAL PRESCRIPTION STRENGTH
Allergy & Congestion Relief
Pseudoephedrine Sulfate 120 mg/Loratadine 5 mg
Extended Release Tablets
Nasal Decongestant/Antihistamine
Compare to Claritin-D® 12 hour Tablets active ingredients
Indoor & outdoor allergies
Non-drowsy*
12 Hour relief of:
nasal and sinus congestion due to colds or allergies
sneezing; runny nose; itchy, watery eyes; itchy throat or nose due to allergies
Actual Size
20 Tablets
*When taken as directed. See Drug Facts Panel.
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INGREDIENTS AND APPEARANCE
SIGNATURE CARE ALLERGY AND CONGESTION RELIEF
loratadine, pseudoephedrine tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-007 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) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND Size 12mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-007-60 20 in 1 CARTON 10/30/2015 1 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 10/30/2015 Labeler - Safeway (009137209)