Sambrosa Care Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your drug product identified above.

Passage 2

your product contains 9.78 mg of doxylamine succinate per each 3 mL dose. The product's directions for use for “adults and children 6 years of age and over,” which read “take 3 mL every 4 to 6 hours. Do not exceed 35 mL in 24 hours." may result in a daily dose of 114.1 mg of doxylamine succinate, which is 76.6 mg of doxylamine succinate more than the daily maximum dose of 37.5 mg that is allowed for children between 6 and 12 years of age and 39.1 mg above the 75 mg daily maximum dose that is allowed for adults and children above 12 years of age under M012.72(d)(8).

Passage 3

your product is labeled to contain the combination of active ingredients that include honey, California poppy, hawthorn, hops, mistletoe, passion flower, oats, and white chestnut. However, none of these ingredients in combination or as sole ingredients are acceptable or recognized as an active ingredient in M012.

Passage 4

“Sambrosa sweet dreams Night Syrup” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.