BABY COLIC- dioscorea villosa tuber, chamomile, and citrullus colocynthis fruit pulp tablet, soluble
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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Baby Colic Tablets

Relieves colic, gas pain and fussiness

Drug Facts

Active ingredients	Purpose
Chamomilla 6X HPUS	restlessness, irritability
Colocynthis 6X HPUS	abdominal pain associated with gas
Dioscorea 6X HPUS	colic pains better from motion

Hyland's Baby Colic Tablets are very soft and will dissolve instantly

in the mouth.

Uses

■ Temporarily relieves symptoms associated with colic in children, including:

■ gas pain ■ irritability ■ restlessness

Warnings

Do not use more than directed.

Consult a physician if symptoms persist for more than 72 hours or worsen .

Keep this and all medications out of the reach of children.

In case of emergency or accidental overdose, 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

3 years

Dissolve 2 tablets on tongue every 15 minutes

up to 8 doses, then every 2 hours until relieved.

Hyland's Baby Colic Tablets are very soft and will dissolve instantly in the mouth.

Other information

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

■ The inner packaged bottle is child-resistant.

Inactive Ingredients

Acacia Gum, Lactose

Questions or comments?

(800) 624-9659

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

HOMEOPATHIC

NDC 54973-3147-1

months

NEW

LOOK

BABY

SINCE 1903
Hyland's

Colic
Tablets*

Relieves colic, gas pain

and fussiness

NO ARTIFICIAL FLAVORS

NO DYES or PARABENS

NATURAL

RELIEF

125 QUICK- DISSOLVING

TABLETS

*SEE NOTE ON BACK

PANEL BELOW DRUG FACTS

carton

BABY COLIC
dioscorea villosa tuber, chamomile, and citrullus colocynthis fruit pulp tablet, soluble

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3147
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA TUBER - UNII:IWY3IWX2G8)	DIOSCOREA VILLOSA TUBER	6 [hp_X]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	6 [hp_X]
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3147-1	125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/31/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/31/2012

Labeler - Hyland's Inc. (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
Hyland's Inc		008316655	manufacture(54973-3147)

Revised: 11/2022

Document Id: ee8ccb70-9599-1d8f-e053-2a95a90abd3e

Set id: 675b4db6-2d77-4bb2-a153-9d522abb2df2

Version: 7

Effective Time: 20221128

Hyland's Inc.