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Is montelukast sodium over the counter from a pharmacy, as dietary supplement or an alternative to medications for the treatment of asthma, epilepsy, or chronic obstructive pulmonary disease. For purposes of this part, "salt" includes table salt, potassium chloride, sodium and hydrochloride, but excludes chloride, or sodium bisulfate. "Contains" "contains more than 1% of sodium" means that the salt meets both of following requirements: (1) All of the salt contains 1% or more sodium. (2) The salt must be derived from natural sea water sources, i.e., from salt water. (e) When sold or offered for sale in any form use as a dietary supplement. (1) All sodium chloride contained in any ingredient substance marketed as a dietary supplement is safe and suitable as a dietary supplement. If the salt is a substitute that derived from natural sea water sources, the salts in this section shall not include sea salt salt. (2) Sodium chloride and salts that are not used as a dietary supplement shall not contain more than the sum of: (i) Total salt content not to exceed 4% of the product by weight salt for a product marketed as dietary supplement, and (ii) The sum of Total Salt Content and Sodium of any other ingredients in the product, than salt, that are the same as or similar to the salt used as a dietary supplement allowed by this subsection is no less than 3% of the product by weight salt. (3) For purposes of this subsection, products manufactured in whole or part the United States include those not manufactured in the United States, regardless of name the exporter. (f) Is listed in the Food and Drug Administration's monograph of approved uses under the Federal Food, Drug, and Cosmetic Act, 21USC § 351. (g) Does not contain added colors, artificial flavors, or vitamins. (10) Is not an over-the-counter food, a prescription drug, drug supplement (other than a product listed in paragraph (e) of this section), or a drug used to treat an adverse health effect Sildenafil online uk or condition that requires a prescription. (g-1) A substance added in accordance with this section, or not otherwise listed montelukast 10 mg hinta in the monograph of approved uses under subsection (10), is exempt from the requirements, restrictions, or limits on the use of that substance in the United States set forth in section 4(d) of the Federal Food, Drug, and Cosmetic Act, 21USC§353(d). (12) Is not an unapproved new drug or product (as those terms are defined in § 101(34) of title 21 the United States Code). (h-5) Is not listed in a monograph published pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act, 21USC§353(a), contains dietary supplement claims that cannot be substantiated in accordance with § 102.30. (i) Is a dietary supplement as defined in § 101(37) and has been approved as such by the FDA. (i-1) Is a dietary supplement as defined in § 101(37) and has had claims substantiated to indicate efficacy or safety in accordance with § 102.30 or an approved use in accordance with subpart.

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