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

BABY CALMING by

Drug Labeling and Warnings

BABY CALMING by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company, MeriCal, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Temporarily relieves the symptoms of occasional sleeplessness, fussiness, agitation, irritability and restless sleep; unpredictable, irregular sleep; waking at night; crying; inconsolable behavior.

Warnings

Consult a physician if:

• symptoms persist for more than 72 hours or worsen
• symptoms are accompanied by a fever

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

The inner packaged bottle is child-resistant. In case of emergency, contact a

medical professional or Poison Control Center immediately. Hyland's may also

be contacted for emergency information about our products 24 hours a day, 7

days a week at (800) 624-9659.

Directions

• children under 6 months of age:

  consult a licensed health care professional

  before using this product

• children 6 months to under 1 year of age:

  dissolve 2 tablets on tongue every 15 minutes

  for 4 doses, then hourly until relieved

• children 1 to under 3 years of age:

  dissolve 3 tablets on tongue every 15 minutes

  for 4 doses, then hourly until relieved

Inactive ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

NDC: 54973-3308-1
HOMEOPATHIC

Natural
Relief

Ages
6 months+

SINCE 1903
Hyland's®
Baby

Daytime

Calming
Tablets

RELIEF OF OCCASIONAL

SLEEPLESSNESS, FUSSINESS,

AND IRRITABILITY*

‣ No Artificial Flavors, Dyes or Parabens

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING TABLETS

INGREDIENTS AND APPEARANCE

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

Product 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

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)