COLIC RELIEF- aethusa cynapium, alumina, belladonna, borax, chamomilla, colocynthis, dioscorea villosa, ipecacuanha, magnesia phosphorica, natrum phosphoricum, nux vomica, plumbum metallicum, pulsatilla, senna, silicea, valeriana officinalis liquid

Colic Relief by

Drug Labeling and Warnings

Colic Relief by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts​

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HPUS active ingredients: Aethusa cynapium, Alumina, Belladonna, Borax, Chamomilla, Colocynthis, Dioscorea villosa, Ipecacuanha, Magnesia phosphorica, Natrum phosphoricum, Nux vomica, Plumbum metallicum, Pulsatilla, Senna, Silicea, Valeriana officinalis. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

INDICATIONS & USAGE

Uses for temporary relief of: abdominal discomfort, pressure, and distention, spitting up, gas and bloating, cramping, pain, irritability, desire to be held constantly, weak digestion, restless sleep.

INACTIVE INGREDIENT

Inactive ingredients: Bio-Energetically Enhanced pure water, citric acid, potassium sorbate.

WARNINGS

Warnings

• Stop use and ask your doctor if symptoms persist or worsen.
• If pregnant or breast-feeding, take only on advice of a healthcare professional.

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions:

• Initially, depress pump until primed.
• Spray one dose directly into mouth.
• Adults 12 and up: 3 sprays 3 times per day.
• Children 2-12: 2 sprays 3 times per day.
• Children 2 mo-2 yr: 1 spray 3 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been independently tested.

PURPOSE

Uses for temporary relief of:

• abdominal discomfort
• pressure and distention
• spitting up
• gas
• bloating
• cramping
• pain
• irritability
• desire to be held constantly
• weak digestion
• restless sleep

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLIC RELIEF 
aethusa cynapium, alumina, belladonna, borax, chamomilla, colocynthis, dioscorea villosa, ipecacuanha, magnesia phosphorica, natrum phosphoricum, nux vomica, plumbum metallicum, pulsatilla, senna, silicea, valeriana officinalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-0158
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C)	AETHUSA CYNAPIUM	10 [hp_X]  in 59 mL
ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933)	ALUMINUM OXIDE	10 [hp_X]  in 59 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	10 [hp_X]  in 59 mL
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	10 [hp_X]  in 59 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	10 [hp_X]  in 59 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	10 [hp_X]  in 59 mL
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8)	DIOSCOREA VILLOSA TUBER	10 [hp_X]  in 59 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	10 [hp_X]  in 59 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	10 [hp_X]  in 59 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	10 [hp_X]  in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	10 [hp_X]  in 59 mL
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P)	LEAD	10 [hp_X]  in 59 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	10 [hp_X]  in 59 mL
SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX)	SENNA LEAF	10 [hp_X]  in 59 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	10 [hp_X]  in 59 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-0158-2	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/22/2012

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(57955-0158)