WAL-ITIN 10 mg/1

LORATADINE · CAPSULE, LIQUID FILLED · WALGREENS

1 Recall on Record

Plain English

WAL-ITIN is a prescription capsule, liquid filled containing loratadine at 10 mg/1, taken oral. Manufactured by WALGREENS.

Key Facts

Brand Name: WAL-ITIN
Generic Name: LORATADINE
NDC Code (Product): 0363-1686
Manufacturer: WALGREENS
Strength: 10 mg/1
Dosage Form: CAPSULE, LIQUID FILLED
Route: ORAL
Marketing Status: HUMAN OTC DRUG
Application #: ANDA206214
Marketing Start: 10/21/2016

Recall History

1 Recall on Record

Class III07/28/2015

Ohm Laboratories, Inc.

Superpotent Drug: Out Of Specification (OOS) result for Assay.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective3,545 reports

fatigue3,228 reports

nausea2,697 reports

dyspnoea2,432 reports

headache2,407 reports

diarrhoea2,365 reports

off label use2,230 reports

dizziness2,064 reports

pain1,981 reports

rash1,617 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 itchy, watery eyes sneezing itching of the nose or throat

Dosage & Administration

Directions chew or crush tablets completely before swallowing. adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours children under 2 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. Ask a doctor before use if you have 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. 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 (1-800-222-1222).

Frequently Asked Questions

What is WAL-ITIN used for?

WAL-ITIN contains LORATADINE. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is WAL-ITIN a controlled substance?

WAL-ITIN is not classified as a controlled substance by the DEA.

What is the generic name for WAL-ITIN?

The generic name for WAL-ITIN is LORATADINE. There are 12 other brand versions of LORATADINE.

What is the NDC code for WAL-ITIN 10 mg/1?

The NDC (National Drug Code) for WAL-ITIN 10 mg/1 is 0363-1686, listed by WALGREENS.

Product NDC

0363-1686

Package NDC

0363-1686-07

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)