BABY COLIC RELIEF- aethusa cynapium, aloe, carbo vegetabilis, chamomilla, colocynthis, mentha piperita, pulsatilla, senna, silicea, valeriana officinalis, zingiber officinale liquid

Baby Colic Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

HPUS Active Ingredients

Aethusa cynapium, Aloe, Carbo vegetabilis, Chamomilla, Colocynthis, Mentha piperita, Pulsatilla, Senna, Silicea, Valeriana officinalis, Zingiber officinale

Inactive Ingredients

Bio-Energetically Enhanced pure water, Carya ovata bark extract (hickory), citrus extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

Directions

• Initially, depress pump until primed
• Spray one dose directly into mouth

Under 6 Months: Consult a licensed healthcare professional before using

6 months to 2 years: 1 spray every 15 minutes, up to 4 doses, then hourly until relieved

2 years and older: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved

Purpose

Aethusa cynapium.............restlessness, irritability

Aloe................................gas reief, bloating, colic before & after stool

Carbo vegetabilis..............gas with colic, upset stomach

Chamomilla......................irritability, ooversensitivity

Colocynthis......................abdominal discomfort

Mentha piperita.................infantile colic, accumulation of gas

Pulsatilla...........................stomach cramps, desire to be held

Senna..............................colic, gas, constipation

Silicea..............................belching, colic

Valeriana officinalis.............irritability, bloating, sleeplessness

Zingiber officinale................digestive aid, colic pain, flatulence

Warnings

Stop use and ask a doctor, if symptoms persist or worsen

If pregnant or breast-feeding, ask a healthcare professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Other Information

This product is intended to compliment, not replace, standard medical care.

Tamper resistant for your protection. Use only if safety seal is intact.

Uses

for temporary relief of symptoms:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY COLIC RELIEF 
aethusa cynapium, aloe, carbo vegetabilis, chamomilla, colocynthis, mentha piperita, pulsatilla, senna, silicea, valeriana officinalis, zingiber officinale liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-0466
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
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9)	ALOE	10 [hp_X]  in 59 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	10 [hp_X]  in 59 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	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
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	10 [hp_X]  in 59 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	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) (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
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
CARYA OVATA BARK (UNII: X765CF609L)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR)
REBAUDIOSIDE A (UNII: B3FUD0528F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-0466-2	1 in 1 CARTON	03/02/2018
1		59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/02/2018

Labeler - King Bio Inc (617901350)

Registrant - King Bio Inc (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc		617901350	manufacture(57955-0466)