![LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]](https://medic.hrt.org//dailymed/images/6cc91178-bfde-4cbf-a3e0-1124ab5ff86a/Loratadine-D 10mg-240mg_70518-0371-00.jpg)
![LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]](https://medic.hrt.org//dailymed/images/6cc91178-bfde-4cbf-a3e0-1124ab5ff86a/Loratadine-D 10mg-240mg_70518-0371-01.jpg)
| NDC | 70518-0371-0, 70518-0371-1 |
| Set ID | 6cc91178-bfde-4cbf-a3e0-1124ab5ff86a |
| Category | HUMAN OTC DRUG LABEL |
| Packager | REMEDYREPACK INC. |
| Generic Name | |
| Product Class | alpha-Adrenergic Agonist |
| Product Number | |
| Application Number | ANDA076557 |
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSE
-
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:
-
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
- sodium: contains 10 mg/tablet
- calcium: contains 25 mg/tablet
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/labels only)
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
- store between 20° C to 25° C (68° F to 77° F).
- protect from light and store in a dry place
-
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
DRUG: Loratadine and Pseudoephedrine Sulfate
GENERIC: Loratadine and Pseudoephedrine Sulfate
DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE
ADMINSTRATION: ORAL
NDC: 70518-0371-0
NDC: 70518-0371-1
COLOR: white
SHAPE: CAPSULE
SCORE: No score
SIZE: 17 mm
IMPRINT: RX724
PACKAGING: 15 in 1 BLISTER PACK
PACKAGING: 5 in 1 BOTTLE PLASTIC
ACTIVE INGREDIENT(S):
- PSEUDOEPHEDRINE SULFATE 240mg in 1
- LORATADINE 10mg in 1
INACTIVE INGREDIENT(S):
- TITANIUM DIOXIDE
- SODIUM CITRATE, UNSPECIFIED FORM
- SODIUM ALGINATE
- SHELLAC
- PROPYLENE GLYCOL
- STARCH, CORN
- POVIDONE, UNSPECIFIED
- TALC
- POLYETHYLENE GLYCOL, UNSPECIFIED
- MAGNESIUM STEARATE
- LACTOSE MONOHYDRATE
- FERROSOFERRIC OXIDE
- HYPROMELLOSE, UNSPECIFIED
- HYDROXYPROPYL CELLULOSE (1600000 WAMW)
- SILICON DIOXIDE
- MICROCRYSTALLINE CELLULOSE
- CALCIUM CARBONATE
-
INGREDIENTS AND APPEARANCE
LORATADINE AND PSEUDOEPHEDRINE SULFATE
loratadine and pseudoephedrine sulfate tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70518-0371(NDC:0904-5833) 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) 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 (white to off-white) Score no score Shape CAPSULE Size 17mm Flavor Imprint Code RX724 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70518-0371-0 15 in 1 BLISTER PACK; Type 0: Not a Combination Product 03/29/2017 03/02/2020 2 NDC:70518-0371-1 5 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/12/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076557 03/29/2017 Labeler - REMEDYREPACK INC. (829572556)