careone allergy relief 10 mg/1

loratadine · TABLET, ORALLY DISINTEGRATING · American Sales Company

1 Recall on Record

Plain English

careone allergy relief is a tablet, orally disintegrating containing loratadine at 10 mg/1, taken oral. Manufactured by American Sales Company.

Key Facts

Brand Name: careone allergy relief
Generic Name: loratadine
NDC Code (Product): 41520-510
Manufacturer: American Sales Company
Strength: 10 mg/1
Dosage Form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Marketing Status
Application #: ANDA076011
Marketing Start: 11/08/2021

Recall History

1 Recall on Record

Class II07/27/2021

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective19,381 reports

fatigue17,292 reports

pain15,347 reports

off label use14,180 reports

headache12,159 reports

rash11,506 reports

nausea11,216 reports

dyspnoea10,443 reports

arthralgia9,988 reports

rheumatoid arthritis9,634 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: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Dosage & Administration

Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 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 or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: 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. (1-800-222-1222)

Frequently Asked Questions

What is careone allergy relief used for?

careone allergy relief contains loratadine. It is a tablet, orally disintegrating taken oral. Consult your doctor for specific uses.

Is careone allergy relief a controlled substance?

careone allergy relief is not classified as a controlled substance by the DEA.

What is the generic name for careone allergy relief?

The generic name for careone allergy relief is loratadine. There are 12 other brand versions of loratadine.

What is the NDC code for careone allergy relief 10 mg/1?

The NDC (National Drug Code) for careone allergy relief 10 mg/1 is 41520-510, listed by American Sales Company.

Product NDC

41520-510

Package NDC

41520-510-65

Other Loratadine Brands

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

Data from openFDA · Public domain (CC0 1.0)