EXTRA STRENGTH GAS RELIEF- simethicone tablet, chewable 
Geri-Care Pharmaceuticals, Corp

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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GC691

Active ingredient (in each tablet)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • adults: chew 1 or 2 tablets as needed after meals and at bedtime
  • do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician

Other information

  • each tablet contains: calcium 89 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • store at controlled room temperature
  • protect from moisture

Inactive ingredients

cherry flavor, D&C red #27 lake, D&C red #30 lake, dextrates, FD&C red #40 lake, silica gel, sorbitol, starch, stearic acid, talc, tri-calcium phosphate

package label

gc

EXTRA STRENGTH GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-691
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DEXTRATES (UNII: G263MI44RU)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorpinkScore2 pieces
ShapeROUNDSize14mm
FlavorCHERRYImprint Code 44;608
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-691-0330 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33211/01/201506/01/2021
Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
Registrant - Geri-Care Pharmaceuticals, Corp (611196254)

Revised: 12/2021
 
Geri-Care Pharmaceuticals, Corp