Match the formulation to the child’s age.
Selected 10 mg tablets and RediTabs direct children under 6 to a doctor; selected 5 mg chewables and 5 mg/5 mL liquid provide directions from age 2. Ask a doctor about liver or kidney disease, and do not exceed the product’s daily dose.
Warnings and precautionsIndications
Temporary relief of allergy symptoms, with product-specific age directions.
Labeled allergy symptom relief
The selected Drug Facts cover runny nose, sneezing, itchy/watery eyes and itching of the nose or throat caused by hay fever or other upper-respiratory allergies. Relief of these symptoms does not establish treatment of their underlying cause.
Scope and other uses
The current selected OTC labels do not list chronic urticaria. Clinician-directed hive treatment, higher-dose antihistamine regimens and combination Claritin-D products require a separate assessment. Desloratadine is a different drug; do not substitute it milligram for milligram.
Dosage and administration
Once-daily directions differ between 10 mg and 5 mg products.
Selected oral directions
| Product | Adults and children age 6 or older | Children age 2 to under 6 |
|---|---|---|
| 10 mg tablet | 1 tablet daily; maximum 1 in 24 hours | Under 6: ask a doctor |
| 10 mg RediTab | 1 tablet daily; maximum 1 in 24 hours | Under 6: ask a doctor |
| 5 mg chewable | Chew 2 tablets daily; maximum 2 in 24 hours | Chew 1 tablet daily; maximum 1 in 24 hours |
| 5 mg/5 mL oral solution | 10 mL daily; maximum 10 mL in 24 hours | 5 mL daily; maximum 5 mL in 24 hours |
Administration by formulation
For the selected liquid, use only its enclosed dosing cup; children under 2 require a doctor. Chew the selected chewable tablets. Place a RediTab on the tongue immediately after opening its individual blister; it dissolves and may be taken with or without water. These are oral products, not injections or nasal sprays.
Liver, kidney disease and dose review
The current Drug Facts direct people with liver or kidney disease to a doctor, who should determine whether a different dose is needed. They provide no numerical organ-adjustment algorithm. Do not turn historical prescription-label directions into a universal current OTC regimen.
Dose safeguards
Check the active ingredient in every allergy/cold product and follow the daily limit. Taking more than directed can cause drowsiness. If symptoms remain troublesome, obtain clinical advice rather than escalating the dose independently.
Safety
Age eligibility, hypersensitivity and organ disease matter even for OTC use.
Warnings and precautions
Ask a doctor before use with liver or kidney disease. Taking more than directed may cause drowsiness; avoid hazardous tasks if you become sleepy. Stop use and obtain medical help immediately if an allergic reaction occurs.
The selected 5 mg chewable contains aspartame and 1.9 mg phenylalanine per tablet, relevant to phenylketonuria. Do not assume every loratadine formulation contains the same excipients. Keep all products away from children.
Contraindications
Do not use after an allergic reaction to loratadine or any ingredient in the selected product. Read the specific inactive-ingredient list when choosing another formulation.
Boxed warning status
The selected U.S. OTC Drug Facts have no boxed warning. Their allergy, overdose, age and organ-disease precautions remain applicable.
Adverse reactions
The current Drug Facts specifically warn about allergic reactions and drowsiness when exceeding directions, without supplying a comprehensive incidence table. Historical prescription studies also describe headache, fatigue, dry mouth and somnolence. Do not interpret OTC status as proof of absence of adverse effects.
Drug interactions
Review other medicines and avoid duplicate antihistamine exposure.
Metabolic interactions
Historical FDA studies found increased loratadine exposure with ketoconazole, erythromycin or cimetidine, without clinically important ECG or safety changes in the studied volunteers. Review these combinations clinically, especially with organ impairment; there is no universal adjustment established by those studies.
OTC combinations and formulation ingredients
Check allergy/cold medicines for duplicate loratadine or additional active ingredients. Claritin-D contains a separate decongestant and needs its own interaction review. The selected chewable’s phenylalanine content matters to people with phenylketonuria.
Use in specific populations
Current OTC directions and pregnancy evidence address different questions.
Pregnancy and lactation
The Drug Facts advise asking a health professional before use during pregnancy or breastfeeding. MotherToBaby’s February 2026 review finds no expected increase in birth-defect risk based on available studies; behavior/learning outcomes have not been studied. Milk transfer is small and loratadine is a preferred breastfeeding antihistamine, but monitor infant sleepiness and discuss possible effects on milk supply. These observations do not make every pregnancy or combination product risk-free.
Children and older adults
Use the formulation-specific age chart. Liquid and selected 5 mg chewables provide directions from age 2; selected 10 mg tablets/RediTabs direct those under 6 to a doctor. The current OTC labels provide no separate geriatric dose. Consider comorbidities and the complete medicine list.
Renal and hepatic considerations
Ask a doctor before use with kidney or liver disease. Historical PK studies show increased exposure in renal impairment and alcoholic liver disease; this explains the need for individualized review but does not supply current product-specific OTC adjustment instructions.
Clinical pharmacology
Peripheral H1 antagonism and an active metabolite contribute to allergy relief.
Mechanism
Loratadine selectively antagonizes peripheral histamine H1 receptors. It is metabolized to the active compound desloratadine.
Pharmacokinetics
Historical FDA data describe rapid oral absorption, metabolism mainly through CYP3A4 and partly CYP2D6, and urinary/fecal elimination of metabolites. Mean half-lives were about 8.4 hours for loratadine and 28 hours for its active metabolite, with considerable variability. These historical parameters support pharmacology context, not new formulation or organ-disease dosing.
Monitoring and counseling
Follow symptoms, tolerability and product-specific dose limits.
Monitoring
Assess allergy-symptom response, sleepiness and hypersensitivity. Recheck concentration, age and the entire OTC/prescription list. The selected Drug Facts do not require a routine laboratory-monitoring schedule; liver/kidney disease requires clinician-directed assessment.
Counseling
Use the selected age-specific once-daily dose, keep the measuring cup with the liquid and open RediTabs only when ready to take them. Ask about pregnancy/breastfeeding or organ disease. Stop and seek immediate medical help for an allergic reaction.
Overdose
Obtain medical help or contact Poison Control immediately after an overdose. Do not use historical emesis or gastric-lavage instructions from an archived prescription label as home treatment.
Product identification
Check active ingredient, strength and formulation rather than brand alone.
Representative tablet · Claritin 10 mg
- Appearance
- White, round tablet
- Imprint
- 458 · Claritin10
- Strength and route
- Loratadine 10 mg · oral
- Labeler
- Bayer HealthCare LLC
Dosage forms and strengths
Selected products are 10 mg tablets, 10 mg RediTabs, 5 mg chewables and 5 mg/5 mL oral solution. The selected liquid has 6 mg sodium per 5 mL; the selected chewable has 1.9 mg phenylalanine per tablet. Other OTC products can differ in strength, excipients and directions. Combination products are outside this profile.
Storage and handling
Store the selected products at 20–25°C. Protect the selected tablet blister from excessive moisture; do not use a bottle with a missing/broken printed foil seal. Do not use open/torn RediTabs or chewable blisters, or liquid with a broken/missing carton tamper seal. Open a RediTab’s individual blister immediately before use. Keep out of children’s reach.
References
Original sources for the clinical and product information.
- DailyMed / Bayer HealthCare LLCClaritin 10 mg tablets · Drug Facts
Current SPL version 12, effective 2025-12-05.
- DailyMed / Bayer HealthCare LLCClaritin RediTabs 10 mg · Drug Facts
Current SPL version 12, effective 2025-12-05.
- DailyMed / Bayer HealthCare LLCChildren’s Claritin 5 mg/5 mL · Drug Facts
Current SPL version 18, effective 2025-05-15.
- DailyMed / Bayer HealthCare LLCChildren’s Claritin 5 mg chewables · Drug Facts
Current SPL version 8, effective 2025-12-05.
- U.S. FDAClaritin · Historical FDA pharmacology reference
Archived 2000 prescription label, used only for pharmacology and interaction studies; not current OTC indications, doses, pregnancy categories or overdose treatment.
- MotherToBaby / OTISLoratadine · Pregnancy and breastfeeding fact sheet
February 1, 2026 public teratology-service review; pregnancy/lactation evidence context only.