COLIC RELIEF- aloe, carbo vegetabilis, carum carvi, chamomilla, foeniculum vulgare, melissa officinale, mentha piperita, prunus spinosa, zingiber officinale liquid

Colic Relief by

Drug Labeling and Warnings

Colic Relief by is a Homeopathic medication manufactured, distributed, or labeled by CVS Pharmacy, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Aloe 5X, Carbo Vegetabilis 1X, Carum Carvi 5X, Chamomilla 5X, Foeniculum Vulgare 5X, Melissa Officinale 5X, Mentha Piperita 5X, Prunus Spinosa 5X, Zingiber Officinale5X.

USES:

Temporarily relieves the symptoms of infant gas, colic, upset stomach, bloating, hiccups.

WARNINGS:

DO NOT USE IF OUTER IMPRINTED SAFETY SEAL ON GLASS BOTTLE OR PROTECTIVE WRAP ON ORAL DISPENSER ARE 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.

 Because product is black, a temporarily, harmless, darkening of the stool may occur.

 May stain fabric; protect clothing and furniture.

KEEP OUT OF REACH OF CHILDREN:

KEEP OUT OF REACH OF CHILDREN.

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

DIRECTIONS:

SHAKE WELL before use to obtain uniform dark mixture.
Remove outer imprinted safety seal from glass bottle and protective wrap on oral dispenser.
When symptoms occur, fill enclosed oral dispenser up to indicated dose level and dispense liquid slowly, drop-by-drop into mouth, between cheek and gums.
If needed, repeat every 30 minutes for up to 3 doses, or as directed by a physician. Do not exceed 4 full doses in 24 hours.
Recap glass bottle and clean oral dispenser.

Weight              Dose
Under 20 lbs.    1/4 teaspoon (1.25 mL)
Over 20 lbs.      1/2 teaspoon (2.5 mL)

OTHER SAFETY INFORMATION:

Please note: Sleep may follow naturally after relief.

STORE AT ROOM TEMPERATURE, OUT OF DIRECT SUNLIGHT.

INDICATIONS:

Temporarily relieves the symptoms of infant gas, colic, upset stomach, bloating, hiccups.

INACTIVE INGREDIENTS:

Citric Acid, Glycerin, Potassium Benzoate, Potassium Citrate, Potassium Sorbate, Purified Water, Xylitol.

QUESTIONS:

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2015 CVS/Pharmacy

CVS.com

1-800-SHOP CVS

PACKAGE LABEL DISPLAY:

CVS        NDC: 59779-542-01
Health

Safe & Fast-Acting
Colic Relief
HOMEOPATHIC MEDICINE
ORAL SUSPENSION
Great Tasting
Relieves gas & Colic
Soothes upset stomach
No artificial flavors
or colors

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

COLIC RELIEF 
aloe, carbo vegetabilis, carum carvi, chamomilla, foeniculum vulgare, melissa officinale, mentha piperita, prunus spinosa, zingiber officinale liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-542
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	5 [hp_X]  in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	1 [hp_X]  in 1 mL
CARAWAY SEED (UNII: W2FH8O2BBE) (CARAWAY SEED - UNII:W2FH8O2BBE)	CARAWAY SEED	5 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	5 [hp_X]  in 1 mL
FENNEL SEED (UNII: G3QC02NIE6) (FENNEL SEED - UNII:G3QC02NIE6)	FENNEL SEED	5 [hp_X]  in 1 mL
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N)	MELISSA OFFICINALIS	5 [hp_X]  in 1 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	5 [hp_X]  in 1 mL
PRUNUS SPINOSA FLOWER BUD (UNII: 53Y84VPS2W) (PRUNUS SPINOSA FLOWER BUD - UNII:53Y84VPS2W)	PRUNUS SPINOSA FLOWER BUD	5 [hp_X]  in 1 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	5 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM BENZOATE (UNII: 763YQN2K7K)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-542-01	1 in 1 CARTON
1		59 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/10/2015

Labeler - CVS Pharmacy (062312574)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(59779-542) , api manufacture(59779-542) , label(59779-542) , pack(59779-542)