Country: United States
Language: English
Source: NLM (National Library of Medicine)
Convallaria Majalis (UNII: QHH4HVF5QE) (Convallaria Majalis - UNII:QHH4HVF5QE)
Newton Laboratories, Inc.
ORAL
OTC DRUG
Aching of legs, Irregular pulse, Headache. Aching of legs, Irregular pulse, Headache.
unapproved homeopathic
CONVALLARIA MAJALIS - CONVALLARIA MAJALIS LIQUID NEWTON LABORATORIES, 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._ ---------- CONVALLARIA MAJALIS INDICATIONS & USAGE SECTION Aching of legs, Irregular pulse, Headache. DOSAGE & ADMINISTRATION SECTION DIRECTIONS: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose. OTC - ACTIVE INGREDIENT SECTION Convallaria majalis 15x, 10x, 30c. OTC - PURPOSE SECTION Aching of legs, Irregular pulse, Headache. INACTIVE INGREDIENT SECTION INACTIVE INGREDIENTS: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%. QUESTIONS SECTION www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256 WARNINGS SECTION WARNINGS: KEEP OUT OF REACH OF CHILDREN. DO NOT USE if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If PREGNANT OR BREAST-FEEDING, ask a doctor before use. OTC - PREGNANCY OR BREAST FEEDING SECTION If PREGNANT OR BREAST-FEEDING, ask a doctor before use. OTC - KEEP OUT OF REACH OF CHILDREN SECTION KEEP OUT OF REACH OF CHILDREN. PACKAGE LABEL Newton Laboratories, Inc. CONVALLARIA MAJALIS convallaria majalis liquid PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:55714-6 174 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CO NVA LLA RIA MA J A LIS (UNII: QHH4HVF5QE) (Co nvallaria Majalis - UNII:QHH4HVF5QE) Co nvallaria Majalis 15 [hp_X] in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH ALCO HO L (UNII: 3K9 9 58 V9 0 M) WA TER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:55714-6 174-1 30 mL in 1 BOTTLE, Read the complete document