Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)
BioActive Nutritional, Inc.
ORAL
OTC DRUG
For temporary relief of fatigue, irritability, insomnia, and exhaustion. For temporary relief of fatigue, irritability, insomnia, and exhaustion.
unapproved homeopathic
MELATONIN- MELATONIN LIQUID BIOACTIVE NUTRITIONAL, INC. _Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for_ _safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective._ ---------- DRUG FACTS: ACTIVE INGREDIENT: Melatonin 6X. INDICATIONS: For temporary relief of fatigue, irritability, insomnia, and exhaustion. WARNINGS: IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in cool, dry place. KEEP OUT OF REACH OF CHILDREN: KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age. INDICATIONS: For temporary relief of fatigue, irritability, insomnia, and exhaustion. INACTIVE INGREDIENTS: Demineralized Water, 25% Ethanol QUESTIONS: Distributed by: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935 bioactivenutritional.com PACKAGE LABEL DISPLAY: BIOActive NUTRITIONAL MELATONIN 6X HOMEOPATHIC 1 FL OZ (30 ML) MELATONIN melatonin liquid PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:438 57-0 511 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH MELATO NIN (UNII: JL5DK9 3RCL) (MELATONIN - UNII:JL5DK9 3RCL) MELATONIN 6 [hp_X] in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) ALCO HO L (UNII: 3K9 9 58 V9 0 M) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:438 57- 0 511-1 30 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n Pro duc t 0 3/22/20 19 BioActive Nutritional, Inc. MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE unappr Lees het volledige document