Label: CAREONE ALLERGY AND CONGESTION RELIEF- loratadine, pseudoephedrine sulfate tablet, film coated, extended release
- NDC Code(s): 41520-918-65
- Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 6, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
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- reduces swelling of nasal passages
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- temporarily relieves sinus congestion and pressure
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- temporarily restores freer breathing through the nose
- Warnings
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Do not use
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- if you have ever had an allergic reaction to this product or any of its ingredients
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- 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
Compare to the active ingredients in Claritin-D® 12 hour
12hr
12 HOUR – Non-Drowsy*
Allergy & Congestion Relief
Pseudoephedrine Sulfate 120 mg/Nasal Decongestant
Loratadine 5 mg/Antihistamine
Extended Release Tablets
Actual Size
30 EXTENDED RELEASE TABLETS
INDOOR & OUTDOOR ALLERGIES
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
OUR PHARMACISTS RECOMMEND
*When taken as directed. See Drug Facts Panel.
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INGREDIENTS AND APPEARANCE
CAREONE ALLERGY AND CONGESTION RELIEF
loratadine, pseudoephedrine sulfate tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-918 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:41520-918-65 30 in 1 CARTON 03/07/2019 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 03/07/2019 Labeler - American Sales Company (809183973)