BABY CALMING- matricaria recutita, arabica coffee bean, strychnos ignatii seed, lycopodium clavatum spore, sodium chloride, platinum, anemone pulsatilla, and sulfur tablet 
Hyland's

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.

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Hyland's Naturals Baby Calming

Drug Facts

Drug Facts

Active ingredientsPurpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Chamomilla 6X HPUSoccasional sleeplessness, fussiness, and agitation
Coffea Cruda 6X HPUSirritability
Ignatia Amara 30X HPUS
(less than 0.0000000000001% Alkaloids, calculated)
restless sleep
Lycopodium 30X HPUSunpredictable, irregular sleep
Natrum Muriaticum 6X HPUScrying, irritability
Platinum Metallicum 30X HPUScauseless crying, waking at night
Pulsatilla 6X HPUScries easily, inconsolable
Sulphur 12X HPUScrying, restlessness, irritability

Uses

■ Temporarily relieves symptoms of irritability or restlessness in children, including:

■ occasional sleeplessness ■ fussiness ■ agitation
■ restless sleep ■ unpredictable or irregular sleep ■ waking at night
■ crying ■ inconsolable behavior


Warnings

Stop use and ask a doctor if: ■ symptoms persist for more than 72 hours or worsen.

■ symptoms are accompanied by a fever.

Keep out of reach of children.

Directions

■ Use as directed.

Children under 6 monthsAsk a doctor before use.
Children 6 months
to under 1 year
At 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 years
At 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

Acacia Gum, Lactose.

Questions or comments?

www.hylands.com or (800) 624-9659

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,
NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Hyland's

Naturals™

•baby•

Calming

Tablets*

NO ARTIFICIAL FLAVORS,

DYES or PARABENS

Sleeplessness

Fussiness

Irritability

6+ MONTHS

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

carton

BABY CALMING 
matricaria recutita, arabica coffee bean, strychnos ignatii seed, lycopodium clavatum spore, sodium chloride, platinum, anemone pulsatilla, and sulfur tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3308
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED30 [hp_X]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_X]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]
PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM30 [hp_X]
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3308-11 in 1 CARTON01/20/2017
1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3308-26 in 1 PACKET; Type 0: Not a Combination Product01/20/201712/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/20/2017
Labeler - Hyland's (028570695)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655manufacture(54973-3308) , pack(54973-3308) , label(54973-3308)
Establishment
NameAddressID/FEIBusiness Operations
MeriCal, Inc.029644978manufacture(54973-3308)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company080253323manufacture(54973-3308) , pack(54973-3308) , label(54973-3308)

Revised: 12/2021
Document Id: d39e88d5-38bc-2f7a-e053-2995a90a9eb2
Set id: 8f20251b-111b-4b7b-8098-4371d04004bd
Version: 5
Effective Time: 20211220
 
Hyland's