EQUALIZER GAS RELIEF - dimethicone suspension/ drops
Hi-Tech Pharmacal Co., Inc.

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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Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

Relieves the symptoms referred to as gas

Warnings

Keep out of the reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

shake well before each use
administer dose 4 times daily after meals and at bedtime. The dosage can also be mixed with 1 oz of cool water, infant formula or other suitable liquid to ease administration.
do not give more than 12 doses in 24 hours
infants under 2 years (under 24 lbs) 0.3 mL
children over 2 years (over 24 lbs) 0.6 mL

Other Information

Sodium Content: 0.15 mg sodium per 0.6 mL.
Store at room temperature

Inactive ingredients

Calcium saccharin, carbopol 934P, citric acid, D&C Red #33, hydroxypropylmethylcellulose, purified water, sodium benzoate, vanillin. Sodium citrate may be used to adjust pH.

Questions or comments?

Call 1-800-262-9010, Mon.-Thurs. 9:00 am - 4:30 pm EST, Fri, 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.

Rev. 785:01 12/08

Package/Label Principal Display Panel

Image of Carton

NDC 50383-785-30

EQUALIZER GAS RELIEF DROPS

Simethicone

(20 mg per 0.3 mL)

Antiflatulent

Suitable for Child and Infant Use

1 fl oz (30 mL)

EQUALIZER GAS RELIEF
simethicone suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50383-785
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (DIMETHICONE)	DIMETHICONE	20 mg in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN CALCIUM
CARBOMER 934
ANHYDROUS CITRIC ACID
D&C RED NO. 33
HYPROMELLOSES
WATER
SODIUM BENZOATE
VANILLIN
SODIUM CITRATE

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50383-785-30	1 BOTTLE in 1 CARTON	contains a BOTTLE
1		30 mL in 1 BOTTLE	This package is contained within the CARTON (50383-785-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	10/01/1991

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Establishment
Name	Address	ID/FEI	Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE

Revised: 08/2011 Hi-Tech Pharmacal Co., Inc.