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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Indications

A homeopathic combination for the temporary relief of 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

Do not use if imprinted cap band is broken or missing. If symptoms persist for more than seven days or worsen, consult a licensed health care professional.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a licensed health care professional before using this product.

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a poison control center immediately. In case of emergency, the manufacturer may be contacted 24 hours a day, 7 days a week at 800/624-9659.

Formula

Dioscorea 3X HPUS, Chamomilla 3X HPUS, Colocynthis 3X HPUS in a base of Lactose N.F.

Directions

For children up to 2 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. Children over 2 years: Dissolve 3 tablets as above, or as recommended by a licensed health care professional. Colic Tablets are very soft and dissolve almost instantly under the tongue. 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.

QUESTIONS?

Call us. 800/624-9659

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Label

NDC 54973-7502-1

Hyland's™
HOMEOPATHIC

Colic Tablets

Symptomatic Relief for Colic in Children
No Side Effects
100% Natural
Soft Tablets Dissolve Instantly

125 TABLETS

Principal Display Panel - 125 Tablet Bottle Label

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-7502
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIOSCOREA VILLOSA TUBER (DIOSCOREA VILLOSA TUBER)	DIOSCOREA VILLOSA TUBER	3 [hp_X]
CHAMOMILE (CHAMOMILE)	CHAMOMILE	3 [hp_X]
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP)	CITRULLUS COLOCYNTHIS FRUIT PULP	3 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE

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

Packaging
#	Item Code	Package Description
1	NDC:54973-7502-1	125 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		01/01/1930	11/15/2011

Labeler - HYLAND'S, INC. (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	MANUFACTURE(54973-7502)

Revised: 04/2013

Document Id: f680d57e-4b5f-49ec-a33d-a68e7b381a76

Set id: c80e2c9a-8e47-4b25-99c7-ead6a2c1ca69

Version: 2

Effective Time: 20130410

HYLAND'S, INC.