TEENY TUMMY
INFANT'S GAS RELIEF DROPS TEENY TUMMY fast instant gas relief INFANT'S GAS RELIEF DROPS
376660a2-becb-48cf-a9f5-6a76a8b8ca70
HUMAN OTC DRUG LABEL
May 28, 2025
ATLANTIC BIOLOGICALS CORP
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Simethicone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
relieves the symptoms referred to as gas
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 0.3 mL)
Simethicone 20 mg
OTC - PURPOSE SECTION
Purpose
Antigas
WARNINGS SECTION
Warnings
Keep out of reach of children.
In case of overdose get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
• shake well before using
• 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
• fill enclosed dropper to recommended dosage level and dispense liquid slowly
into baby’s mouth, toward the inner cheek
• dosage can also be mixed with 1 oz. of cool water, infant formula or other
suitable liquids
• clean dropper well after each use and replace original cap on bottle
|
Age (years) |
Weight (lbs) |
Dose |
|
infants under 2 |
under 24 |
0.3 mL |
|
children over 2 |
over 24 |
0.6 mL |
STORAGE AND HANDLING SECTION
Other information
TAMPER-EVIDENT*:**Do not use if printed seal under cap is broken or punctured
- store at room temperature
- do not freeze
- see bottom panel for lot number and expiration date
INACTIVE INGREDIENT SECTION
Inactive ingredients
Carboxymethylcellulose sodium, Citric acid, Flavor strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum.
Questions or comments ?
Call toll-free 1-877-225-6999.
DISTRIBUTED BY:
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179