FDA Label for Infants Gas Relief
View Indications, Usage & Precautions
Infants Gas Relief Product Label
The following document was submitted to the FDA by the labeler of this product Family Dollar (family Wellness). The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 lbs | under 2 years | 0.3 mL |
over 24 lbs | over 2 years | 0.6 mL |
Other Information
- store between 20-25°C (68-77°F)
- 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
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COMPARE TO THE ACTIVE INGREDIENT IN MYLICON® GAS RELIEF*
Infants Gas Relief
Simethicone 20 mg - antigas
- Gently breaks down baby's gas bubbles
- Safe enough to use at every feeding**
Dye-Free
Alcohol-Free
Non-staining
Saccharin free
FL OZ (mL)
Dosing syringe
Use only with enclosed syringe
**use as directed
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
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
10611 MONROE RD.,
MATTHEWS, NC 28105
Package Label
FAMILY WELLNESS Infant's Gas Relief
* Please review the disclaimer below.