Hyland’s Baby Calming Tablets, Natural Relief of Occasional Sleeplessness, Fussiness, And Irritability, 125 Count Temporarily relieves the symptoms of occasional sleeplessness, fussiness, agitation, irritability and restless sleep; unpredictable, irregular sleep; waking at night; crying; inconsolable behaviors. NATURAL REMEDIES SINCE 1903 Hyland's has been producing homeopathic medicines since 1903. Hyland's products are made in the United States with natural ingredients, and contain no artificial flavors, dyes or parabens. SAFE AND RELIABLE Homeopathy is a safe system of medicine with fundamental principles for selection and application, working to stimulate to the body's own healing properties. Homeopathic preparations (6X, 30X, 30C) dilute and invigorate the source ingredient, making doses non-toxic and safe to take alongside other medications without contraindications or known side effects. Always read and follow the label directions when using Hyland's products FDA REGULATED MANUFACTURING Hyland's products follow the manufacturing and quality requirements outlined in the Homeopathic Pharmacopoeia of the United States and the applicable provisions of the Code of Federal Regulations. Hyland's facilities are regulated and inspected by FDA. Hyland's facilities use the most up-to-date equipment and environment to assure purity and quality. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.