Baby Colic (Dioscorea Villosa Tuber, Chamomile, And Citrullus Colocynthis Fruit Pulp) Tablet, Soluble [Hyland's] -

BABY COLIC (DIOSCOREA VILLOSA TUBER, CHAMOMILE, AND CITRULLUS COLOCYNTHIS FRUIT PULP) TABLET, SOLUBLE [HYLAND'S]
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NDC	54973-3147-1
Set ID	675b4db6-2d77-4bb2-a153-9d522abb2df2
Category	HUMAN OTC DRUG LABEL
Packager	Hyland's
Generic Name
Product Class
Product Number
Application Number

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Drug Facts

Active ingredients	Purpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Chamomilla 6X HPUS	restlessness & irritability
Colocynthis 6X HPUS	abdominal pain caused by gas
Dioscorea 6X HPUS	colic pains better from motion

Uses

Temporarily relieves the symptoms of colic and gas pains caused by irritating food, feeding too quickly, swallowing air and similar conditions during teething, colds and other minor upset periods in children.
Warnings

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 3 years of age: dissolve 2 tablets on tongue every 15 minutes for up to 8 doses until relieved; then every 2 hours as required.

If you prefer, tablets may be dissolved in a teaspoon of water and then given to the child. Hyland's Baby Colic Tablets are very soft and dissolve instantly in the mouth.

Please note: if your baby has been crying or is very upset, your baby may fall asleep after using this product because the pain has been relieved and your child can rest.
Inactive Ingredients

Acacia Gum, Lactose
SPL UNCLASSIFIED SECTION

Manufactured for: Hyland's, Inc.
Los Angeles, CA 90061
PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

NDC 54973-3147-1

HOMEOPATHIC

Ages

0 months+

SINCE 1903
Hyland's ®
Baby

Natural
Relief

Colic
Tablets

RELIEF OF COLIC
GAS PAIN AND IRRITABILITY*

No Artificial Flavors, Dyes or Parabens

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING TABLETS

INGREDIENTS AND APPEARANCE

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 (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(54973-3147)

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Medic

BABY COLIC (DIOSCOREA VILLOSA TUBER, CHAMOMILE, AND CITRULLUS COLOCYNTHIS FRUIT PULP) TABLET, SOLUBLE [HYLAND'S]

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