Loratadine / pseudoephedrine

Temporary relief of allergy-related sneezing, itchy/watery eyes, runny nose and nose/throat itching; nasal congestion from colds or upper-respiratory allergies, sinus congestion/pressure and nasal swelling. It does not treat the underlying viral illness. FDA records list both selected strengths as OTC.

12 Hour: one 5 mg loratadine / 120 mg pseudoephedrine sulfate tablet every 12 hours, maximum two tablets in 24 hours. 24 Hour: one 10 mg / 240 mg tablet daily with a full glass of water, maximum one in 24 hours. Do not divide, crush, chew or dissolve either tablet. Below 12 ask a doctor; there is no self-care pediatric schedule supplied.

If symptoms fail to improve within 7 days, fever accompanies them, or nervousness/dizziness/sleeplessness occurs, stop and ask a doctor. In liver or kidney disease, a doctor must determine whether a different dose is needed; current Drug Facts do not supply an eGFR-based schedule. Do not import standalone loratadine adjustments into this fixed extended-release combination.

Selected U.S. Drug Facts say do not use with prior allergy to this product/ingredients, while taking a prescription MAOI, or for 2 weeks after its discontinuation. The listed chronic conditions are ask-a-doctor precautions; the separately described EMA contraindications belong to EU regulatory scope.

Neither selected current U.S. OTC label has a boxed warning. MAOI exclusion and serious decongestant precautions remain clinically relevant.

Current labels identify nervousness, dizziness and sleeplessness as stop-and-consult symptoms; allergy needs immediate help. Higher-than-directed dosing may cause drowsiness. Drug Facts do not provide incidence estimates or a complete systemic-event frequency table. For overdose contact Poison Help or seek medical help promptly; keep out of children’s reach.

Do not use during MAOI therapy or for 2 weeks afterward; have a pharmacist identify uncertain antidepressant/Parkinson medicines. Review other allergy/cold preparations to avoid duplicating either active ingredient. Archived standalone loratadine studies found higher exposure with ketoconazole, erythromycin or cimetidine without significant ECG changes in those healthy volunteers; this does not establish safety of a decongestant combination in a high-risk patient. Current Drug Facts do not supply a complete interaction-based dose algorithm.

Self-care directions begin at 12. Below 12 ask a doctor; do not split an adult extended-release tablet to create a child dose. The current OTC labels give no separate geriatric schedule; associated cardiac, urinary, renal/hepatic conditions require review.

If pregnant or breastfeeding, ask a health professional before use. Current combination Drug Facts do not establish a trimester-specific dose, milk-exposure estimate or universal safe-use claim; a standalone antihistamine’s pregnancy evidence does not clear the decongestant component.

Do not self-adjust: both labels direct consumers with kidney or liver disease to a doctor to decide whether a different dose is needed. EMA’s separate EU review prohibits pseudoephedrine with severe kidney disease/failure because of PRES/RCVS risk; no executable renal reduction is inferred here.

Loratadine antagonizes peripheral histamine H1 receptors; its active metabolite contributes to antihistamine effects. Archived standalone studies describe CYP3A4/2 D 6 metabolism and urinary/fecal metabolite elimination. EMA describes pseudoephedrine-mediated noradrenaline release and vasoconstriction that reduce nasal swelling. Current selected combination Drug Facts do not provide detailed absorption, binding, half-life or organ-impairment PK values, so no combination-specific numeric PK estimate is invented.

Before use review MAOIs/recent stopping, heart/thyroid/blood-pressure/diabetes history, urinary symptoms and kidney/liver disease. Follow symptom response, sleep, dizziness and nervousness; consult if no improvement within 7 days or with fever. There is no routine laboratory panel specified by Drug Facts.

Use only the chosen product’s schedule and swallow whole; 24 Hour requires a full glass of water. Do not take extra doses or duplicate loratadine/pseudoephedrine in another OTC product. Know the stop-and-consult symptoms and obtain immediate help for allergy. Ask about pregnancy/breastfeeding and store securely away from children.

Bayer Claritin-D 12 Hour: loratadine 5 mg and pseudoephedrine sulfate 120 mg per extended-release tablet. Example NDC 11523-7162-1, 10-tablet carton. Verify the blister seal and package directions.

Selected 12 Hour tablets: 5 mg / 120 mg; 24 Hour tablets: 10 mg / 240 mg. Pseudoephedrine is the sulfate salt, not a milligram-for-milligram substitution instruction for another salt/formulation. FDA NDA 019670 and NDA 020470 currently list these products OTC. Combination liquids, compounded formulations and other antihistamine/decongestant combinations are excluded.

Store both at 20–25°C in a dry place; 24 Hour additionally says protect from light. Do not use an open/torn individual blister. The selected 12 Hour tablet contains calcium 30 mg; 24 Hour calcium 25 mg. Keep intact and away from children.