Cetirizine Hydrochloride

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL can be taken without regard to food consumption.
• Children 2 to 5 Years for Chronic Urticaria:
• The recommended initial dose of Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL in children aged 2 to 5 years is 2.5 mg (2.5 mL) once daily.
• The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 5 mL once a day, or 2.5 mL given every 12 hours.
• Children 6 Months to <2 Years for Perennial Allergic Rhinitis and Chronic Urticaria:
• The recommended dose of Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL in
• children 6 months to 23 months of age is 2.5 mg (2.5 mL) once daily.
• The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as 2.5 mL (2.5 mg) every 12 hours.

Quoted from the official label, section “Dosage & Administration”.

Side effects

• Pediatric studies were conducted with cetirizine hydrochloride.
• More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with cetirizine hydrochloride at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States.
• The duration of treatment ranged from 2 to 12 weeks.
• Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received cetirizine, the majority of whom received single daily doses of 5 mg.
• A placebo-controlled trial 18 months in duration included 399 patients aged 12 to 24 months treated with cetirizine (0.25 mg/kg bid), and another placebo-controlled trial of 7 days duration included 42 patients aged 6 to 11 months who were treated with cetirizine (0.25 mg/kg bid).
• The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with cetirizine hydrochloride were mild or moderate.
• In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in pediatric patients receiving up to 10 mg of cetirizine hydrochloride was uncommon (0.4% on cetirizine hydrochloride vs. 1.0% on placebo).
• Table 1 lists adverse experiences which were reported for cetirizine hydrochloride 5 and 10 mg in pediatric patients aged 6 to 11 years in placebo-controlled clinical trials in the United States and were more common with cetirizine hydrochloride than placebo.
• Of these, abdominal pain was considered treatment-related and somnolence appeared to be dose-related, 1.3% in placebo, 1.9% at 5 mg and 4.2% at 10 mg.
• The adverse experiences reported in pediatric patients aged 2 to 5 years in placebo-controlled trials were qualitatively similar in nature and generally similar in frequency to those reported in trials with children aged 6 to 11 years.
• In the placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences, were similar in the cetirizine and placebo treatment groups in each study.
• Somnolence occurred with essentially the same frequency in patients who received cetirizine and patients who received placebo.
• In a study of 1 week duration in
• children 6-11 months of age, patients who received cetirizine exhibited greater irritability/fussiness than patients on placebo.
• In a study of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received cetirizine compared to patients who received placebo (9.0% v. 5.3%).
• In those patients who received 5 mg or more per day of cetirizine as compared to patients who received placebo, fatigue (3.6% v. 1.3%) and malaise (3.6% v. 1.8%) occurred more frequently.
• Table 1.
• Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States Cetirizine Hydrochloride Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥ 2% in Either the 5-mg or the 10-mg Cetirizine Hydrochloride Group, and More Frequently Than in the Placebo Group Adverse Experiences Placebo (N=309) Cetirizine hydrochloride 5 mg (N=161) 10 mg (N=215) Headache 12.3% 11.0% 14.0% Pharyngitis 2.9% 6.2% 2.8% Abdominal pain 1.9% 4.4% 5.6% Coughing 3.9% 4.4% 2.8% Somnolence 1.3% 1.9% 4.2% Diarrhea 1.3% 3.1% 1.9% Epistaxis 2.9% 3.7% 1.9% Bronchospasm 1.9% 3.1% 1.9% Nausea 1.9% 1.9% 2.8% Vomiting 1.0% 2.5% 2.3% The following events were observed infrequently (less than 2%), in either 3982
• adults and children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received cetirizine hydrochloride in U.S. trials, including an open adult study of six months duration.
• A causal relationship of these infrequent events with cetirizine hydrochloride administration has not been established.
• Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention.
• Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.
• Central and Peripheral Nervous Systems:
• abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine, myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.
• Gastrointestinal:
• abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.
• Genitourinary:
• cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.
• Hearing and Vestibular: deafness, earache, ototoxicity, tinnitus.
• Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.
• Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.
• Psychiatric:
• abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder.
• Respiratory System:
• bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.
• Reproductive:
• dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis.
• Reticuloendothelial: lymphadenopathy.
• Skin:
• acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.
• Special Senses: parosmia, taste loss, taste perversion.
• Vision:
• blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmia.
• Body as a Whole:
• accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.
• Occasional instances of transient, reversible hepatic transaminase elevations have occurred during cetirizine therapy.
• Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of cetirizine hydrochloride has been reported.
• Post-Marketing Experience In the post-marketing period, the following additional rare, but potentially severe adverse events have been reported:
• aggressive reaction, anaphylaxis, cholestasis, convulsions, glomerulonephritis, hallucinations, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, suicidal ideation, suicide, thrombocytopenia, acute generalized exanthematous pustulosis (AGEP) and new onset pruritis-pruritis within a few days after discontinuation of cetirizine, usually after long-term use (e.g., months to years) of cetirizine.

Quoted from the official label, section “Adverse Reactions”.

How to store it

Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]; or Store refrigerated, 2°-8°C (36°-46°F).

Quoted from the official label, section “Storage and Handling”.

Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

86 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

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