Label: RXHOMEO HOMEOPATHIC COMBO kit
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Contains inactivated NDC Code(s)
NDC Code(s): 15631-2483-0 - Packager: Rxhomeo Private Limited d.b.a.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 Label Information
Updated October 13, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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USES
A homeopathic combination pack with two single remedies Passiflora Incarnata and Kali Phosphoricum for relief of sleeplessness.
Passiflora Incarnata; Uses: Passiflora Incarnata is a chief remedy for insomnia or sleeplessness. Passiflora helps in quietning the nervous system and induces normal sleep. Restlessness and wakeful sleep especially in the feeble, infants, and the aged with history of mental worries and over work.
Kali Phosphoricum;Uses: Kali Phosphoricum helps in insomnia or sleeplessness after worry or excitement from nervous causes. Also walking in sleep in children. - INDICATIONS
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DOSAGE
PELLETS included in the Combo
Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.
TABLETS included in the Combo
Adults- Take 4 or 6 Tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.
- WARNINGS
- INACTIVE INGREDIENTS
- STORAGE
- QUESTIONS OR COMMENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RXHOMEO HOMEOPATHIC COMBO
rxhomeo homeopathic combo kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15631-2483 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15631-2483-0 1 in 1 CONTAINER 10/10/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 Part 2 1 Part 1 of 2 PASSIFLORA INCARNATA
passiflora incarnata pelletProduct Information Item Code (Source) NDC:15631-0331 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 1 [hp_X] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic Part 2 of 2 KALI PHOSPHORICUM
kali phosphoricum tabletProduct Information Item Code (Source) NDC:15631-0612 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 1 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) Product Characteristics Color white Score no score Shape ROUND Size 3mm Flavor Imprint Code Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/10/2016 Labeler - Rxhomeo Private Limited d.b.a. (650833994) Establishment Name Address ID/FEI Business Operations Rxhomeo Private Limited d.b.a. Rxhomeo, Inc 650833994 manufacture(15631-2483) , label(15631-2483)
