TEENY TUMMY GAS RELIEF DROPS- simethicone suspension

TEENY TUMMY by

Drug Labeling and Warnings

TEENY TUMMY by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP, UNIT DOSE SOLUTIONS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

relieves the symptoms referred to as gas

Warnings

Keep out of reach of children.
In case of overdose get medical help or contact a Poison Control Center right away.

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

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 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TEENY TUMMY  GAS RELIEF DROPS
simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-1141(NDC:71399-0041)
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-1141-1	120 in 1 BOX, UNIT-DOSE	09/12/2024
1	NDC: 17856-1141-6	0.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 17856-1141-2	120 in 1 BOX, UNIT-DOSE	09/12/2024
2	NDC: 17856-1141-7	0.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 17856-1141-3	120 in 1 BOX, UNIT-DOSE	09/12/2024
3	NDC: 17856-1141-8	0.6 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4	NDC: 17856-1141-4	120 in 1 BOX, UNIT-DOSE	09/12/2024
4	NDC: 17856-1141-9	0.6 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	08/04/2023

Labeler - ATLANTIC BIOLOGICALS CORP (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
UNIT DOSE SOLUTIONS		360804194	repack(17856-1141)