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Fertility: Limited data is available on human fertility but no safety concern has been identified.
Animal data show no safety concern for human reproduction.
Pregnancy: Caution should be exercised when prescribing to pregnant women. For Cetirizine, prospectively collected data on pregnancy outcomes do not suggest potential for maternal or fetal/embryonic toxicity above background rates.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition, or postnatal development.
Lactation: Cetirizine passes into breast milk. A risk of side effects in breastfed infants cannot be excluded. Caution should be exercised when prescribing Cetirizine to lactating women. Cetirizine is excreted in human milk at concentrations representing 25% to 90% of those measured in plasma, depending on sampling time after administration.
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