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gas relief extra strength by SUPERVALU INC.

Medically reviewed on January 8, 2018

Dosage form: tablet, chewable
Ingredients: SIMETHICONE 125mg
Labeler: SUPERVALU INC.
NDC Code: 41163-635

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.

Equaline 44-635

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 (1-800-222-1222) 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
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number

Inactive ingredients

 D&C yellow #10 aluminum lake, dextrates, flavors, maltodextrin, silicon dioxide, sorbitol, starch, stearic acid, talc, triacetin, tri-calcium phosphate

Questions or comments?

1-877-932-7948

Principal display panel

NDC 41163-635-44             compare to Gas-X® Extra Strength active ingredient*

EQUALINE®

extra strength
gas relief
tablets

simethicone 125mg
(anti-gas)

peppermint
creme flavor

relieves:
bloating
• pressure
• discomfort

18 chewable tablets                          actual size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DOES NOT CONTAIN GLUTEN                                    50844     ORG091363544

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Gas-X® Extra Strength.

DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA
we're committed to your satisfaction and guarantee the quality of this product. Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com. Please have package available.

Equaline 44-635

GAS RELIEF  EXTRA STRENGTH
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-635
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
DEXTRATES 
MALTODEXTRIN 
SILICON DIOXIDE 
SORBITOL 
STEARIC ACID 
TALC 
TRIACETIN 
Product Characteristics
ColorYELLOWScore2 pieces
ShapeROUNDSize14mm
FlavorPEPPERMINTImprint Code44;635
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-635-442 BLISTER PACK in 1 CARTON
19 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33210/01/2013
Labeler - SUPERVALU INC. (006961411)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(41163-635)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(41163-635)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(41163-635)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(41163-635)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(41163-635)

 
SUPERVALU INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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