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- NDC Code(s): 11523-0102-1, 11523-0102-2
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 30, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
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- SPL UNCLASSIFIED SECTION
Drug Facts
- ACTIVE INGREDIENT
Active ingredient (in each tablet) Purpose Loratadine 10 mg Antihistamine Pseudoephedrine sulfate 240 mg Nasal decongestant - 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
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
- Warnings
Do not use
See Alsod 24 OVAL WHITE Images- 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.
Stop use and ask a doctor if
- an allergic reaction to this product occurs. Seek medical help right away.
- symptoms do not improve within 7 days or are accompanied by a fever
- nervousness, dizziness or sleeplessness occurs
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions
- do not divide, crush, chew or dissolve the tablet
adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor - Other information
- store between 20° to 25°C (68° to 77°F)
- protect from light and store in a dry place
- Inactive ingredients
black iron oxide, candelilla wax powder, Inactive ingredients colloidal silicon dioxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, propylene glycol, sodium lauryl sulfate, talc, titanium dioxide
- Questions or comments?
1-800-CLARITIN (1-800-252-7484) or www.claritin.com
- PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton
Non-Drowsy*
Claritin-D
®pseudoephedrine sulfate 240 mg/nasal decongestant
loratadine 10 mg/antihistamine
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.
5
EXTENDED
RELEASE TABLETS
- INGREDIENTS AND APPEARANCE
CLARITIN-D24 HOUR
loratadine pseudoephedrine sulfate tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10mg PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 240mg Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SODIUM LAURYL SULFATE (UNII: 368GB5141J) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) TALC (UNII: 7SEV7J4R1U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CANDELILLA WAX (UNII: WL0328HX19) HYPROMELLOSES (UNII: 3NXW29V3WO) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (white to off-white) Score no score Shape OVAL Size 18mm Flavor Imprint Code Andrx;605 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-0102-1 1 in 1 CARTON 12/12/2022 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:11523-0102-2 1 in 1 CARTON 12/12/2022 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 ANDA075706 12/12/2022 Labeler -Bayer HealthCare LLC.(112117283)
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More Info on this Drug
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View Labeling Archives for this drug
CLARITIN-D 24 HOUR- loratadine pseudoephedrine sulfate tablet, extended release
Number of versions: 8
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Dec 1, 2023 | 8 (current) | download |
| Dec 12, 2022 | 7 | download |
| May 3, 2022 | 6 | download |
| Jan 28, 2022 | 5 | download |
| Nov 19, 2019 | 4 | download |
| Jul 20, 2017 | 3 | download |
| May 11, 2017 | 2 | download |
| Sep 4, 2013 | 1 | download |
RxNorm
CLARITIN-D 24 HOUR- loratadine pseudoephedrine sulfate tablet, extended release
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 1117562 | pseudoephedrine sulfate 240 MG / loratadine 10 MG 24HR Extended Release Oral Tablet | PSN |
| 2 | 1117562 | 24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet | SCD |
| 3 | 1117562 | loratadine 10 MG / pseudoephedrine sulfate 240 MG 24 HR Extended Release Oral Tablet | SY |
| 4 | 1242391 | Claritin-D 10 MG / 240 MG 24HR Extended Release Oral Tablet | PSN |
| 5 | 1242391 | 24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet [Claritin-D] | SBD |
| 6 | 1242391 | Claritin-D (loratadine 10 MG / pseudoephedrine sulfate 240 MG) 24 HR Extended Release Oral Tablet | SY |
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NDC Codes
CLARITIN-D 24 HOUR- loratadine pseudoephedrine sulfate tablet, extended release
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 11523-0102-1 |
| 2 | 11523-0102-2 |
