Drugplain

DYE-FREE CHILDRENS LORATADINE 5 mg/1

LORATADINE · TABLET, CHEWABLE · SAFEWAY

No Recall History
Plain English

Dye-Free Children's Loratadine is an over-the-counter antihistamine used to relieve allergy symptoms such as sneezing, runny nose, and itchy eyes in children. This chewable tablet form contains loratadine without artificial dyes and is taken by mouth.

Key Facts

Brand Name
DYE-FREE CHILDRENS LORATADINE
Generic Name
LORATADINE
NDC Code (Product)
21130-646
Manufacturer
SAFEWAY
Strength
5 mg/1
Dosage Form
TABLET, CHEWABLE
Route
ORAL
Marketing Status
Application #
ANDA210088
Marketing Start
09/01/2020

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective3,545 reports
fatigue3,226 reports
nausea2,696 reports
dyspnoea2,432 reports
headache2,407 reports
diarrhoea2,365 reports
off label use2,229 reports
dizziness2,065 reports
pain1,979 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 DYE-FREE CHILDRENS LORATADINE used for?

Dye-Free Children's Loratadine is an over-the-counter antihistamine used to relieve allergy symptoms such as sneezing, runny nose, and itchy eyes in children. This chewable tablet form contains loratadine without artificial dyes and is taken by mouth.

Is DYE-FREE CHILDRENS LORATADINE a controlled substance?

DYE-FREE CHILDRENS LORATADINE is not classified as a controlled substance by the DEA.

What is the generic name for DYE-FREE CHILDRENS LORATADINE?

The generic name for DYE-FREE CHILDRENS LORATADINE is LORATADINE. There are 12 other brand versions of LORATADINE.

What is the NDC code for DYE-FREE CHILDRENS LORATADINE 5 mg/1?

The NDC (National Drug Code) for DYE-FREE CHILDRENS LORATADINE 5 mg/1 is 21130-646, listed by SAFEWAY.

Product NDC

21130-646

Package NDC

21130-646-20

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)