Label: GAS RELIEF DROPS- dimethicone liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 4, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 0.3mL)

    Simethicone 20mg

  • 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 this and all drugs out of the reach of children

    In case pf overdose get medical help or contact a poison control center right away.

  • 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 replace original cap.
    age (yr)weight (lb)dose
    infants under 2under 240.3mL
    children 2 and overover 240.6 mL
  • Other information

    Store between 15°-30°C (59°-86° F). Avoid exposing bottle to excessive heat and direct sunlight. Do not accept if safety seal is broken or missing. Keep box for information.

  • Inactive ingredients

    Anise oil, carbomer, glycerin, methylparaben, propylparaben, purified water, sodium citrate and sucralose.

  • Questions or Comments?

  • SPL UNCLASSIFIED SECTION

    Distributed by: Arymar Inc.
    8004 NW 154 St. # 343
    Miami Lakes FL 33016

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

    Arymar®

    Gas Relief
    Drops

    Simethicone - Anti-Gas

    Safe enough to use
    every feeding

    ● No Alcohol ● No Saccharin
    ● No Artificial Colors
    ● No Artificial Flavors

    1 Fl. Oz. (30 ml)

    Arymar®

    Principal Display Panel - 30 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    GAS RELIEF DROPS 
    dimethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70570-0197
    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
    Anise Oil (UNII: 6Y89129C8H)  
    Carboxypolymethylene (UNII: 0A5MM307FC)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70570-0197-11 in 1 CARTON02/01/2015
    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 FINALpart33202/01/2015
    Labeler - Arymar Inc. (021650273)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!