LITTLE REMEDIES COLIC RELIEF- chamomilla, foeniculum vulgare, melissa officinalis liquid
Denison Pharmaceuticals, 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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Little Remedies
Advanced Colic Relief Drops

Suggested Use


Weight (lbs)	Dose (5 mL)
6 to under 9	1 - 2 times per day
9 to under 13	2 - 3 times per day
13 to under 17	3 - 4 times per day
17 and up	4 - 6 times per day

Active Ingredients

Chamomilla..........................142mg

Foeniculum Vulgare...............131mg

Melissa Officinalis..................77mg

Shake Well

Use only the enclosed syringe to ensure accurate closing.

Purpose

Colic Relief

Keep out of reach of children.

In some infants, a rare allergic reaction may occur. Do not exceed recommeneded dosage.

Warning

Always consult your health care provider before giving this or any supplemt to an infant

store at room temperature
this product is intended for use under adult supervision

Questions?

1-800-754-8853

Mon. - Fri. 8 am to 8 pm EST

LittleRemedies.com

Inactive Ingredients

purified water, agave syrup, glycerin, natural ginger flavor, citric acid, potassium benzoate, xanthan gum.

PRINCIPAL DISPLAY PANEL

Little Remedies
Colic Relief

Little Remedies Colic Relief

LITTLE REMEDIES COLIC RELIEF
chamomilla, foeniculum vulgare, melissa officinalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0295-1189
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	142 mg in 5 mL
FENNEL SEED (UNII: G3QC02NIE6) (FENNEL SEED - UNII:G3QC02NIE6)	FENNEL SEED	142 mg in 5 mL
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	77 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)
GLYCERIN (UNII: PDC6A3C0OX)
GINGER (UNII: C5529G5JPQ)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
POTASSIUM BENZOATE (UNII: 763YQN2K7K)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0295-1189-17	1 in 1 BOX	01/01/2017	01/01/2017
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:0295-1189-15	1 in 1 BOX	01/01/2017	01/01/2017
2		88 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:0295-1189-05	1 in 1 BOX	01/01/2017	01/01/2017
3		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2017	01/01/2017

Labeler - Denison Pharmaceuticals, Inc. (001207208)

Name	Address	ID/FEI	Business Operations
Establishment
Denison Pharmaceuticals, Inc.		001207208	MANUFACTURE(0295-1189)

Revised: 1/2017

Document Id: daa8ff02-b410-45e8-801d-959b7b8ffec9

Set id: 55dea4cf-9982-4ce6-a83e-27798794524c

Version: 2

Effective Time: 20170101

Denison Pharmaceuticals, Inc.

Little RemediesAdvanced Colic Relief Drops