INFANTS GAS RELIEF- simethicone suspension

Infants Gas Relief by

Drug Labeling and Warnings

Infants Gas Relief by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 24	under 2 years	0.3 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

INGREDIENTS AND APPEARANCE

INFANTS GAS RELIEF 
simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0325
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
MALTITOL (UNII: D65DG142WK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49580-0325-1	1 in 1 BOX	06/30/2015	12/31/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	06/30/2015	12/31/2020

Labeler - P & L Development, LLC (101896231)