GAS AND BLOATING REAL RELIEF - citrullus colocynthis fruit pulp, magnesium phosphate, dibasic trihydrate, matricaria recutita and dioscorea villosa tuber tablet, chewable 
HOMEOLAB USA 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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ACTIVE INGREDIENTS HPUS

Colocynthis (Bitter apple) 8X
Magnesia phosphorica (Magnesium hydrogen phosphate) 8X
Chamomilla (German chamomile) 8X
Dioscorea villosa (Wild yam) 8X

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

abdominal bloating, colic and nausea
abdominal cramps
nausea, agitation and irritability
intestinal gas, burping and colic-like pain

USES

This homeopathic medicine helps relieve symptoms of gas and bloating:

- gas pain

- nausea

- burping

- irritability

WARNINGS


Stop use and ask a doctor if symptoms worsen or persist for more than 3 days.

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

Keep out of reach of children.

DIRECTIONS

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat every 4 hours and reduce intake with improvement or as directed by a health professional.


Age
 Dose
Adults and children 12 years of age and older2 tablets
Children 2 to 11 years of age1 tablet
Children under 2 years of ageAsk a doctor

OTHER INFORMATION

Store at room temperature (68 - 77F).

Do not use if seal is broken or missing.

INACTIVE INGREDIENTS

Lactose, magnesium stearate.


CARTON

image of carton label


GAS AND BLOATING  REAL RELIEF
colocynthis, magnesia phosphorica, chamomilla, dioscorea villosa tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-6005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP8 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM CATION8 [hp_X]
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA8 [hp_X]
DIOSCOREA VILLOSA TUBER (DIOSCOREA VILLOSA TUBER) DIOSCOREA VILLOSA TUBER8 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
MAGNESIUM STEARATE 
Product Characteristics
ColorwhiteScore no score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:60512-6005-090 TABLET, CHEWABLE in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/25/2012

Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIOperations
HOMEOLAB USA INC202032533manufacture

Revised: 07/2012 HOMEOLAB USA INC