Label: LORATADINE AND PSEUDOEPHEDRINE tablet, extended release
- NDC Code(s): 70677-1018-1, 70677-1018-2
- Packager: STRATEGIC SOURCING SERVICES LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 11, 2023
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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
- 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
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily restores freer breathing through the nose
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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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
- diabetes
- trouble urinating due to an enlarged prostate gland
- liver or kidney disease. Your doctor should determine if you need a different dose.
- DIRECTIONS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
Calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton
NDC 70677-1018-1
COMPARE TO CLARITIN-D®
24 HOUR ACTIVE INGREDIENTS†Foster & Thrive™
ORIGINAL PRESCRIPTION STRENGTH
Allergy Relief-D
Loratadine, USP 10 mg/ANTIHISTAMINE
Pseudoephedrine Sulfate, USP 240 mg/NASAL DECONGESTANTNon-Drowsy*
Indoor & Outdoor Allergies | Allergy & Congestion
24 hour 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
ACTUAL SIZE
10 Extended-Release Tablets
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INGREDIENTS AND APPEARANCE
LORATADINE AND PSEUDOEPHEDRINE
loratadine and pseudoephedrine tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1018 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 240 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM ALGINATE (UNII: C269C4G2ZQ) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code RX724 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1018-1 1 in 1 CARTON 08/10/2023 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:70677-1018-2 1 in 1 CARTON 08/10/2023 2 15 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 ANDA076557 08/10/2023 Labeler - STRATEGIC SOURCING SERVICES LLC (116956644) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(70677-1018)