Drugplain

Claritin-D 12 Hour 5 mg/1

Loratadine and pseudoephedrine sulfate · TABLET, EXTENDED RELEASE · Bayer HealthCare LLC.

No Recall History
Plain English

Claritin-D 12 Hour is a tablet, extended release containing loratadine and pseudoephedrine sulfate at 5 mg/1, taken oral. Manufactured by Bayer HealthCare LLC..

Key Facts

Brand Name
Claritin-D 12 Hour
Generic Name
Loratadine and pseudoephedrine sulfate
NDC Code (Product)
11523-7162
Manufacturer
Bayer HealthCare LLC.
Strength
5 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA019670
Marketing Start
12/01/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,528 reports
insomnia672 reports
drug effect decreased395 reports
product use issue381 reports
dizziness324 reports
somnolence258 reports
headache253 reports
nausea231 reports
fatigue217 reports
dyspnoea203 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings

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. 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Claritin-D 12 Hour used for?

Claritin-D 12 Hour contains Loratadine and pseudoephedrine sulfate. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is Claritin-D 12 Hour a controlled substance?

Claritin-D 12 Hour is not classified as a controlled substance by the DEA.

What is the generic name for Claritin-D 12 Hour?

The generic name for Claritin-D 12 Hour is Loratadine and pseudoephedrine sulfate. There are 11 other brand versions of Loratadine and pseudoephedrine sulfate.

What is the NDC code for Claritin-D 12 Hour 5 mg/1?

The NDC (National Drug Code) for Claritin-D 12 Hour 5 mg/1 is 11523-7162, listed by Bayer HealthCare LLC..

Product NDC

11523-7162

Package NDC

11523-7162-1

Other Loratadine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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