Label: CALM N RESTFUL 4 KIDS- aconitum napellus root, calcium phosphate, chamomile, artemisia cina pre-flowering top, lycopodium clavatum spore, sodium chloride, pulsatilla vulgaris, and sulfur tablet
- NDC Code(s): 54973-3161-1
- Packager: Hyland's
- 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.
Updated December 9, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
Active ingredients Purpose Aconitum Napellus 6X HPUS physical & mental restlessness Calcarea Phosphorica 12X HPUS peevishness Chamomilla 6X HPUS irritability, restlessness, occasional sleeplessness Cina 6X HPUS irritability of temper Lycopodium 6X HPUS lack of focus, extreme sensitivity Natrum Muriaticum 6X HPUS irritability, crying, oversensitivity Pulsatilla 6X HPUS occasional sleeplessness from travel Sulphur 6X HPUS irritability, peevishness
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Consult a physician if:
- Symptoms persist for more than 7 days or worsen
- Child is taking any prescription medicines
Keep this and all medications out of the reach of children.
In case of accidental overdose, contact a medical professional or a poison control center immediately.
Children 2 years to under 6 years dissolve 2 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required Children 6 years to under 12 years dissolve 3 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required Adults and children 12 years and over dissolve 4 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton
INGREDIENTS AND APPEARANCE
CALM N RESTFUL 4 KIDS
aconitum napellus root, calcium phosphate, chamomile, artemisia cina pre-flowering top, lycopodium clavatum spore, sodium chloride, pulsatilla vulgaris, and sulfur tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3161 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X) ACONITUM NAPELLUS ROOT 6 [hp_X] CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE 12 [hp_X] CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 6 [hp_X] ARTEMISIA CINA PRE-FLOWERING TOP (UNII: 28M1820ACT) (ARTEMISIA CINA PRE-FLOWERING TOP - UNII:28M1820ACT) ARTEMISIA CINA PRE-FLOWERING TOP 6 [hp_X] LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 6 [hp_X] SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 [hp_X] Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE (UNII: J2B2A4N98G) Product Characteristics Color white Score no score Shape ROUND Size 5mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3161-1 1 in 1 CARTON 06/10/2013 1 125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/10/2013 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3161)