Label: LORATADINE AND PSEUDOEPHEDRINE SULFATE tablet, extended release
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-488-15, 49035-488-69 - Packager: WAL-MART STORES, INC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 29, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 15 Tablet Bottle Carton
equate™
NON-DROWSY*
Allergy Relief &
Nasal Decongestant
Loratadine, USP 10mg/Antihistamine
Pseudoephedrine Sulfate,
USP 240mg/Nasal Decongestant
INDOOR AND OUTDOOR ALLERGIES
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
Original prescription strength
*When taken as directed. See Drug Facts Panel.NDC 49035-488-15
Compare to
Claritin-D® 24Hr
active ingredients**24
HOURActual Size
15
EXTENDED-
RELEASE
TABLETS -
INGREDIENTS AND APPEARANCE
LORATADINE AND PSEUDOEPHEDRINE SULFATE
loratadine and pseudoephedrine sulfate tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-488 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, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 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) 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:49035-488-15 15 in 1 CARTON; Type 0: Not a Combination Product 06/15/2020 2 NDC:49035-488-69 10 in 1 CARTON; Type 0: Not a Combination Product 06/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076557 06/15/2020 Labeler - WAL-MART STORES, INC (051957769) Registrant - Sun Pharmaceutical Industries, Inc. (139261648) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries, Inc. 139261648 MANUFACTURE(49035-488)