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SIMETHICONE
Infants

Infants SIMETHICONE ATLANTIC BIOLOGICALS CORP. FDA Approved Uses relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Generic: SIMETHICONE

Mfr: ATLANTIC BIOLOGICALS CORP. FDA OTC

Substance Dimethicone

Route

ORAL

Applications

M002

Product NDC

17856-1303-00 17856-1303-01 17856-1303-02 17856-1303-03 17856-1303-04 17856-1303-05

Package NDC

17856-1303-1 17856-1303-2 17856-1303-3 17856-1303-4 17856-1303-5

Drug Facts

Composition & Profile

Active Ingredients

Active ingredient (in each 0.3 mL) Simethicone 20 mg

Inactive Ingredients

Inactive ingredients carboxymethylcellulose sodium citric acid flavors microcrystalline cellulose polysorbate 60 potassium sorbate purified water sodium benzoate sorbitan monostearate sorbitol xanthan gum Questions or comments? 1-800-645-2158

Strengths

0.3 ml 20 mg

Treats Conditions

Uses Relieves The Discomfort Of Infant Gas Frequently Caused By Air Swallowing Or Certain Formulas Or Foods

Pill Appearance

Color: white

Identifiers & Packaging

Container Type UNKNOWN

NDC 17856-1303-00

All Product Codes

17856-1303-00 17856-1303-01 17856-1303-02 17856-1303-03 17856-1303-04 17856-1303-05

UNII

92RU3N3Y1O

SPL Set IDs

27fce442-e328-41d2-bab9-87ab21550c04

Packaging

Principal Display Panel Infants’ Simethicone Drops Antigas •Dye-free•Non-staining formula•No Saccharin•No Artificial Color•No Artificial Flavor Distributed by: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179 image description image description image description image description image description image description

Package Descriptions

Principal Display Panel Infants’ Simethicone Drops Antigas •Dye-free•Non-staining formula•No Saccharin•No Artificial Color•No Artificial Flavor Distributed by: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179 image description image description image description image description image description image description

Overview

Uses relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Indications & Usage

Uses relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Dosage & Administration

Directions shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child. remove cap and insert syringe into the bottle. pull syringe up until filled to the prescribed level, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards inner cheek). all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. do not exceed 12 doses per day. dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids. Replace cap tightly to maintain child resistance mL = milliliter Age (yr) Weight (lb) Dose (mL) infants under 2 under 24 0.3 children over 2 over 24 0.6

Warnings & Precautions

Warnings Keep out of reach of children. Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Purpose

Purpose Antigas

Keep Out of Reach of Children

Keep out of reach of children. Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Storage & Handling

Other information tamper evident: do not use if printed seal under cap is broken or missing Store at room temperature do not freeze see bottom panel for lot number and expiration date

Questions

Questions or comments? 1-800-645-2158