Colic Calm by Denison Pharmaceuticals, Inc. Colic Calm

Colic Calm by

Drug Labeling and Warnings

Colic Calm by is a Homeopathic medication manufactured, distributed, or labeled by Denison Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLIC CALM- carbo vegetababilis, carum carvi, chamomilla, foeniculum vulgare, melissa officinalis, mentha piperita, prunus spinosa, zingiber officinale 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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Colic Calm

Active Ingredient

Active Ingredients

Carbo Vegetabilis 1x, Carum Carvi 3X, Chamomilla 3X, Foeniculum Vulgare 3X, Melissa Officinalis 3X, Mentha Piperita 3x, Prunus Spinosa 3X, Zingiber Officinale 3X

Purpose

• gas relief, upset stomach
• digestive aid
• irritability, hiccups
• gas relief
• irritability, restlessness
• bloating, colic
• upset stomach, colic
• digestive aid

Uses

Temporarily relieves the symptoms of infant:

colic, gas, reflux, upset stomach, bloating, hiccups

Warnings

• Do not use if protective wrap on oral dispenser is broken or missing.
• Stop use and consult a doctor if symptoms last more than 7 days or inflammation, fever, or infection occurs.
• As with all medications, it is important to ensure that your child’s medical professional is aware of the use of this product.
• As our product is black, a temporary harmless darkening of stool may occur.
• May stain fabric; take care to protect clothing and furniture.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Weight under 20 lbs (9kg) Dose 1/4 teaspoon (1.25 ml)

Weight over 20 lbs (9kg) Dose 1/2 teaspoon (2.5 ml)

• Remove protective wrap from oral dispenser.
• Shake well before use.
• Fill enclosed dispenser up to indicated dose level and dispense liquid slowly (drop by drop) into mouth, between cheek and gums.
• If needed, repeat every 60 minutes for up to 3 doses. Do not exceed 4 full doses in 24 hours.
• Recap bottle and clean dispenser after use.
• Discard remaining product after 3 weeks.

Other Information

• Please notes: sleep may follow naturally after relief
• Store at room temperature, out of direct sunlight

Inactive Ingredients:

Benzoic acid, citric acid (anhydrous), glycerin, potassium citrate, potassium sorbate, purified water, xantural 180, xytilol

Questions?

Call 941-203-4590 visit www.coliccalm.com

PRINCIPAL DISPLAY PANEL

COLIC CALM 
carbo vegetababilis, carum carvi, chamomilla, foeniculum vulgare, melissa officinalis, mentha piperita, prunus spinosa, zingiber officinale liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9028
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FENNEL SEED (UNII: G3QC02NIE6) (FENNEL SEED - UNII:G3QC02NIE6)	FENNEL SEED	3 [hp_X]  in 1000 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	1 [hp_X]  in 1000 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	3 [hp_X]  in 1000 mL
PRUNUS SPINOSA FLOWER BUD (UNII: 53Y84VPS2W) (PRUNUS SPINOSA FLOWER BUD - UNII:53Y84VPS2W)	PRUNUS SPINOSA FLOWER BUD	3 [hp_X]  in 1000 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	3 [hp_X]  in 1000 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	3 [hp_X]  in 1000 mL
CARAWAY SEED (UNII: W2FH8O2BBE) (CARAWAY SEED - UNII:W2FH8O2BBE)	CARAWAY SEED	3 [hp_X]  in 1000 mL
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	3 [hp_X]  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
BENZOIC ACID (UNII: 8SKN0B0MIM)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9028-12	1 in 1 CARTON	12/18/2020
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/18/2020

Labeler - Denison Pharmaceuticals, Inc. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	manufacture(0295-9028)

Revised: 5/2021

Document Id: c2b2accb-cba6-36b5-e053-2995a90a9028

34390-5

Set id: b6c40027-cfbd-bff8-e053-2a95a90aeca9

Version: 2

Effective Time: 20210519