Active Ingredient
Meclizine Hydrochloride 25 mg
Sea-calm
FDA Label NDC 59961-123
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bellegrove for the product Sea-calm (NDC 59961-123). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiemetic
Uses
For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness
Warnings
Do not take this product if you have asthma, glaucoma, emphysema, chronic pulmonary disease, shortness of breath, difficulty in breathing, or difficulty in urination due to enlargement of the prostate gland, unless directed by a physician. Do not give to children under 12 years of age unless directed by a physician. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
Directions
Adult oral dosage is one to two tablets once daily or as directed by a physician.
Inactive Ingredients
Crosscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid and Vanilla Flavor.
Package/Label Principal Display Panel
Container Label For Sea-calm Packet (2 Tablets)
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