HEALTH MART SIMETHICONE- simethicone  emulsion 
McKesson

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Health Mart Simethicone infants gas relief drops

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Warnings


When using this product

do not exceed 12 doses per day

Keep out of the reach of children.

In case of overdose get medical help or contact a poison control center immediately.

Directions

  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommended dosage level
  • dispense liquid slowly into baby's mouth, toward the inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper after each use and close the bottle to maintain child resistance.
    age (yr)   weight (lb)    
    		dose             
    infants under 2   
    		under 24   0.3 mL
    children over 2   
    		over 24   0.6 mL

Other information

store at room temperature (59oF-86oF)

Inactive ingredients

bezoic acid, carboxymethylcellulose sodium, D and C red # 22, D and C red # 28, flavor, glyceryl monostearate, magnesium aluminum silicate, polysorbate, purified water, sorbitol, xanthan gum.

May contain hydrogen chloride, sorbic acid, sorbitan monostearate

Principal Display Panel

Health Mart Pharmacy

compare to Infant's Mylicon active ingredient

infants' gas relief drops

simethicone 20 mg

soothing relief for pressure, bloating and gas symptoms

1 fl oz (30 mL)infants gas relief drug factsinfants gas relief

HEALTH MART SIMETHICONE 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0139
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62011-0139-11 in 1 CARTON04/01/201212/10/2018
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/01/201212/10/2018
Labeler - McKesson (177667227)

Revised: 12/2018
Document Id: 7b5aea67-ed97-42e6-9cc1-a8dbca29f59d
Set id: 1eaf131b-6742-4561-ac8a-2d6097d52655
Version: 2
Effective Time: 20181210
 
McKesson