Baby Colic Relief: Homeopathic Product Information

BABY COLIC RELIEF- aethusa cynapium, aloe, activated charcoal, matricaria chamomilla, citrullus colocynthis fruit pulp, mentha piperita, anemone pulsatilla, senna leaf, silicon dioxide, valerian and ginger liquid
King Bio 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.

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

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AETHUSA CYNAPIUM (AETHUSA CYNAPIUM) AETHUSA CYNAPIUM 10 [hp_X] in 59 mL
ALOE (ALOE) ALOE 10 [hp_X] in 59 mL
ACTIVATED CHARCOAL (ACTIVATED CHARCOAL) ACTIVATED CHARCOAL 10 [hp_X] in 59 mL
MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 10 [hp_X] in 59 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP 10 [hp_X] in 59 mL
MENTHA PIPERITA (MENTHA PIPERITA) MENTHA PIPERITA 10 [hp_X] in 59 mL
ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 10 [hp_X] in 59 mL
SENNA LEAF (SENNA LEAF) SENNA LEAF 10 [hp_X] in 59 mL
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE 10 [hp_X] in 59 mL
VALERIAN (VALERIAN) VALERIAN 10 [hp_X] in 59 mL
GINGER (GINGER) GINGER 10 [hp_X] in 59 mL
Inactive Ingredients
Ingredient Name Strength
CARYA OVATA BARK
CITRUS BIOFLAVONOIDS
LONICERA JAPONICA FLOWER
POLYEPSILON-LYSINE (4000 MW)
REBAUDIOSIDE A
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57955-0466-2 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
1 59 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (57955-0466-2)
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 Operations
King Bio Inc 617901350 manufacture (57955-0466)

Revised: 03/2018 King Bio Inc

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