CHAMOMILLA- matricaria chamomilla tablet 
Hyland's Inc.

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 Baby Comfort Chamomilla

Drug Facts

Active ingredients

Active ingredients

Purpose

Chamomilla 6X HPUS

occasional sleeplessness, fussiness, and irritability

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

Temporarily relieves the symptoms of occasional sleeplessness, fussiness, and irritability

Warnings

Do not use:  • more than directed.  • if you have a known allergy to any ingredient in this product.

Consult a physician if symptoms persist for more than 7 days or worsen.

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 band is broken or missing.

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 per 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 2 years of age:

dissolve 2 tablets under tongue every 15 minutes for 3 doses, then 2-3 times daily until

relieved.

Inactive ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

RELIEF OF OCCASIONAL SLEEPLESSNESS, FUSSINESS AND IRRITABILITY

PRINCIPAL DISPLAY PANEL - 125 TABLET BOTTLE CARTON

New!

NDC 54973-3347-1

HOMEOPATHIC

SINCE 1903

Hyland's®

Baby

Natural

Relief

Comfort

Chamomilla

One Active Ingredient

RELIEF OF

OCCASIONAL

SLEEPLESSNESS,

FUSSINESS AND

IRRITABILITY*

No Artificial Flavors,

Dyes or Parabens

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING TABLETS

Carton

CHAMOMILLA 
matricaria chamomilla tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3347
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
ACACIA (UNII: 5C5403N26O)  
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3347-11 in 1 CARTON02/02/2018
1125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/02/2018
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-3347) , pack(54973-3347) , label(54973-3347)

Revised: 12/2022
Document Id: ef432678-afb8-22df-e053-2a95a90a4d65
Set id: 642ce868-c89d-7851-e053-2991aa0a6e06
Version: 2
Effective Time: 20221207
 
Hyland's Inc.