CALMING- matricaria recutita, arabica coffee bean, strychnos ignatii seed, lycopodium clavatum spore, sodium chloride, platinum, pulsatilla vulgaris, datura stramonium, 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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CALMING TABLETS

Drug Facts

Active ingredientsPurpose
"HPUS" indicates 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 6X HPUSrestless sleep
Lycopodium 30X HPUSunpredictable, irregular sleep
Natrum Muriaticum 6X HPUScrying, irritability
Platinum Metallicum 30X HPUScauseless crying, waking at night
Pulsatilla 6X HPUScries easily, inconsolable
Stramonium 6X HPUSinconsolable, restless sleep
Sulphur 12X HPUScrying, restlessness, irritability

Uses

Temporarily relieves the symptoms of occasional sleeplessness, fussiness, agitation, irritability and restless sleep; unpredictable, 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. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

children under 6 months of ageconsult a licensed health care professional before using this product
children 6 months to under 1 year of agedissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved
children 1 to under 3 years of agedissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved

Other information

  • do not use if imprinted tamper band is broken or missing
  • Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659

Inactive ingredients

Acacia Gum, Lactose N.F.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

NDC 54973-3195-1
HOMEOPATHIC

SINCE 1903
Hyland's
Baby

Natural
Relief

Calming
Tablets

NATURAL RELIEF OF
OCCASIONAL SLEEPLESSNESS,
FUSSINESS, AND IRRITABILITY*

No Artificial Flavors, Dyes or Parabens

125 QUICK-DISSOLVING TABLETS

Principal Display Panel - 125 Tablet Bottle Carton
CALMING 
matricaria recutita, arabica coffee bean, strychnos ignatii seed, lycopodium clavatum spore, sodium chloride, platinum, pulsatilla vulgaris, datura stramonium, and sulfur tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3195
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 SEED6 [hp_X]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_X]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]
PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM30 [hp_X]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM6 [hp_X]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
LACTOSE (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3195-11 in 1 CARTON09/19/201412/22/2017
1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/19/201412/22/2017
Labeler - Hyland's (028570695)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655manufacture(54973-3195) , pack(54973-3195)

Revised: 12/2017
Document Id: 60f2e19c-e8ef-f595-e053-2a91aa0a1c7c
Set id: 737811da-0c1e-490e-af48-e58f8b7b7145
Version: 3
Effective Time: 20171222
 
Hyland's