Label: BABY CALMING- matricaria recutita, arabica coffee bean, strychnos ignatii seed, lycopodium clavatum spore, sodium chloride, platinum, anemone pulsatilla, and sulfur tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 54973-3308-1, 54973-3308-2 - 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.
Drug Label Information
Updated December 20, 2021
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Drug Facts
Drug Facts
Active ingredients Purpose "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Chamomilla 6X HPUS occasional sleeplessness, fussiness, and agitation Coffea Cruda 6X HPUS irritability Ignatia Amara 30X HPUS
(less than 0.0000000000001% Alkaloids, calculated)restless sleep Lycopodium 30X HPUS unpredictable, irregular sleep Natrum Muriaticum 6X HPUS crying, irritability Platinum Metallicum 30X HPUS causeless crying, waking at night Pulsatilla 6X HPUS cries easily, inconsolable Sulphur 12X HPUS crying, restlessness, irritability - Uses
- Warnings
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Directions
■ Use as directed.
Children under 6 months Ask a doctor before use. Children 6 months
to under 1 yearAt onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved. Children 1 year
to under 3 yearsAt onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved. - Inactive ingredients
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- OTHER SAFETY INFORMATION
- PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BABY CALMING
matricaria recutita, arabica coffee bean, strychnos ignatii seed, lycopodium clavatum spore, sodium chloride, platinum, anemone pulsatilla, and sulfur tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3308 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 6 [hp_X] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 6 [hp_X] STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 30 [hp_X] LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 30 [hp_X] SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM 30 [hp_X] ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE, UNSPECIFIED FORM (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:54973-3308-1 1 in 1 CARTON 01/20/2017 1 125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3308-2 6 in 1 PACKET; Type 0: Not a Combination Product 01/20/2017 12/20/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/20/2017 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3308) , pack(54973-3308) , label(54973-3308) Establishment Name Address ID/FEI Business Operations MeriCal, Inc. 029644978 manufacture(54973-3308) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 080253323 manufacture(54973-3308) , pack(54973-3308) , label(54973-3308)