GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled 
NORTHEAST PHARMA (Heartland Pharma)

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Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Use

Warnings

Stop use and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Directions

Other information

Inactive ingredients

FD&C red #40*,FD&C yellow # 6, gelatin, glycerin

Questions or comments?

Call 1-800-383-0648

Principal Display Panel

Compare to active ingredient in PHAZYME® ULTRA STRENGTH†

Ultra Strength

GAS RELIEF

Simethicone, 180 mg | Antigas

Fast relief of:

Softgels

**This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Ultra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: NORTHEAST PHARMA

South Burlington, VT 05403

www.heartlandpharmaco.com

Package Label

Simethicone 180 mg

HEARTLAND PHARMA Ultra Strength Gas Relief

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-792
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code 05A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80136-792-0160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/25/202106/25/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00206/25/202106/25/2025
Labeler - NORTHEAST PHARMA (Heartland Pharma) (081232935)

Revised: 4/2024
Document Id: 6eb57536-3e23-454c-90b7-2b721934c7b2
Set id: 6834d4e5-df95-424c-9724-1f4efc748cf0
Version: 3
Effective Time: 20240411
 
NORTHEAST PHARMA (Heartland Pharma)