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Infants Gas Relief by P & L Development, LLC

Medically reviewed on August 6, 2018

Dosage form: suspension
Ingredients: SIMETHICONE 20mg in 0.3mL
Labeler: P & L Development, LLC
NDC Code: 49580-0325

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.

Drug Facts

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

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

Warnings

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddenings
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetamnophen. Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  • shake well before using
  • mL=milliliter
  • measure only with enclosed syringe provided. Do not use any other dosing device
  • keep dosing device with product
  • replace cap tightly to maintain child resistance
  • remove cap and insert syringe into hole at top of the bottle and turn upside down
  • pull back syringe until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until have reached the desired level. Slowly dispense the liquid into your child's mouth (towards inner cheek)
  • dosage can also be mixed with 1 oz, cool water, infant formula, or other suitable liquids
  • clean syringe well after use
  • 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
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age
Weight (lb)Age (yr) Dose (mL)*
under 24under 2 years0.3 mL
24-35 over 2 years

 0.6 mL

Other information
  • store between 20-25ºC (68-77ºF)
  • do not freeze

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to active ingredient in Mylicon® Gas Relief*

Infants Gas Relief

Simethicone 20 mg

antigas

dye-free

alcohol free

saccharin free

non-staining

FL OZ (mL)

Use only with enclosed syringe

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND THE BOTTLE IS BROKEN OR MISSING

*This product is not manufactured or distributed by McNeil Consumer Healthcrae, distributor of Mylicon® Gas Relief

Manufactured by

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Package Label

ReadyInCase Infants Gas Relief

INFANTS GAS RELIEF 
simethicone suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0325
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
MALTITOL 
CELLULOSE, MICROCRYSTALLINE 
WATER 
SODIUM BENZOATE 
TRISODIUM CITRATE DIHYDRATE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:49580-0325-11 BOTTLE in 1 BOX
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33206/30/2015
Labeler - P & L Development, LLC (101896231)

 
P & L Development, LLC

← See all Infants Gas Relief brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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