Label: LORATADINE AND PSEUDOEPHEDRINE- loratadine and pseudoephedrine sulfate tablet, extended release
- NDC Code(s): 11822-9990-0, 11822-9990-5
- Packager: Rite Aid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 9, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
- 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
-
PRINCIPAL DISPLAY PANEL - 15 Tablet Blister Pack Carton
24 HOUR
Compare to the active ingredients of Claritin-D® 24 Hour**NDC 11822-9990-5
ORIGINAL PRESCRIPTION STRENGTH
ALLERGY RELIEF &
NASAL DECONGESTANT
LORATADINE, USP 10 mg / PSEUDOEPHEDRINE SULFATE, USP 240 mgANTIHISTAMINE & NASAL DECONGESTANT
NON-DROWSY*
INDOOR / OUTDOOR ALLERGIES
24 HOUR RELIEF OFNasal & 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
15
EXTENDED-
RELEASE TABLETS -
PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton
NDC 11822-9990-0
24 HOURCompare to the active ingredients in
Claritin-D® 24 Hour**ORIGINAL PRESCRIPTION STRENGTH
ALLERGY RELIEF &
NASAL DECONGESTANTLORATADINE, USP 10 mg / PSEUDOEPHEDRINE SULFATE, USP 240 mg
ANTIHISTAMINE & NASAL DECONGESTANT
NON-DROWSY*
INDOOR / OUTDOOR ALLERGIES
24 HOUR RELIEF OF
Nasal & sinus congestion due to colds or allergiesSneezing • 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 -
INGREDIENTS AND APPEARANCE
LORATADINE AND PSEUDOEPHEDRINE
loratadine and pseudoephedrine sulfate tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-9990 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:11822-9990-5 1 in 1 CARTON 11/17/2004 1 15 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:11822-9990-0 1 in 1 CARTON 11/17/2004 2 10 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 11/17/2004 Labeler - Rite Aid (014578892) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(11822-9990)