Country: United States
Language: English
Source: NLM (National Library of Medicine)
Pinene 9X, 12X, 30X, 60X
Professional Complementary Health Formulas
ORAL
OTC DRUG
For the temporary relief of bronchitis, skin irritation, nausea, or lightheadedness due to sensitivity to phenolic compounds found in foods or other products.* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
unapproved homeopathic
PINENE 1536- PINENE LIQUID PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS _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._ ---------- YPIN ACTIVE INGREDIENTS Pinene 9X, 12X, 30X, 60X QUESTIONS Professional Formulas PO Box 2034 Lake Oswego, OR 97035 INDICATIONS For the temporary relief of bronchitis, skin irritation, nausea, or lightheadedness due to sensitivity to phenolic compounds found in foods or other products.* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. WARNINGS In case of overdose, get medical help or contact a poison control center right away. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use. DIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age. OTHER INFORMATION Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat. INACTIVE INGREDIENTS 20% ethanol, purified water. LABEL Est 1985 Professional Formulas Complementary Health Pinene Homeopathic Remedy 1 FL. OZ. (29.5 mL) PINENE 1536 pinene liquid PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:63083-1536 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH PINENE (UNII: 996299PUKB) (PINENE - UNII:996299PUKB) PINENE 9 [hp_X] in 29.5 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Professional Complementary Health Formulas PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:63083- 1536-1 29.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/15/1985 MARKETING INFORMATION MARKETING CATEGORY APPLICATION N Read the complete document