| NDC | 62795-1115-2 |
| Set ID | 23b540c5-ed00-4858-b23e-33537969a03e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | MediNatura Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
-
WARNINGS
WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
If symptoms persist or worsen, or if sleeplessness persists continuously for more than 2 weeks, consult your doctor.
Insomnia may be a symptom of serious underlying medical illness.
Do not use if sensitivity to Calm Plus or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.
- KEEP OUT OF REACH OF CHILDREN
- USES
-
ACTIVE INGREDIENTS
Active Ingredients:
Each tablet contains equal parts of Avena sativa 2X; Chamomilla 2X; Humulus lupulus 2X; Passiflora incarnata 2X; Calcarea phosphorica 6X; Kali phosphoricum 6X; Kali sulphuricum 6X; Magnesia phosphorica 6X; Natrum muriaticum 6X; Natrum sulphuricum 6X; Zincum valerianicum 6X; Coffea cruda 12X; Nux vomica 12X; Sulphur 12X
- INACTIVE INGREDIENTS
- DIRECTIONS
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CALM PLUS
avena sativa flowering top, matricaria recutita, passiflora incarnata flowering, tribasic calcium phosphate, dibasic potassium phosphate, potassium sulfate, magnesium phosphate, dibasic, sodium chloride, sodium sulfate, zinc valerate dihydrate, arabica coffee bean, strychnos nux-vomica seed, and sulfur tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62795-1115 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 2 [hp_X] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 2 [hp_X] PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X] TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 2 [hp_X] DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE 6 [hp_X] POTASSIUM SULFATE (UNII: 1K573LC5TV) (SULFATE ION - UNII:7IS9N8KPMG) POTASSIUM SULFATE 6 [hp_X] MAGNESIUM PHOSPHATE, DIBASIC (UNII: A1Y870209Z) (MAGNESIUM PHOSPHATE, DIBASIC - UNII:A1Y870209Z) MAGNESIUM PHOSPHATE, DIBASIC 6 [hp_X] SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 6 [hp_X] ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE 6 [hp_X] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 12 [hp_X] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 12 [hp_X] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape RECTANGLE Size 9mm Flavor Imprint Code Leafman Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62795-1115-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2016 Labeler - MediNatura Inc (079324099) Establishment Name Address ID/FEI Business Operations MediNatura Inc 102783016 manufacture(62795-1115)
