PEDIACARE GAS RELIEF DROPS DYE FREE- simethicone emulsion and simethicone liquid

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Dostępny od:

Medtech Products Inc.

INN (International Nazwa):

SILICON DIOXIDE

Skład:

SILICON DIOXIDE 0.011 g in 1 mL

Droga podania:

ORAL

Typ recepty:

OTC DRUG

Wskazania:

Anti-Gas relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Status autoryzacji:

OTC monograph final

Charakterystyka produktu

PEDIACARE GAS RELIEF DROPS DYE FREE- SIMETHICONE EMULSION AND
SIMETHICONE LIQUID
MEDTECH PRODUCTS INC.
_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._
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PEDIACARE GAS RELIEF DROPS DYE FREE
_DRUG FACTS_
_ACTIVE INGREDIENT_
(in each 0.3 mL)
Simethicone Emulsion USP 66.7mg/Simethicone 20 mg
_PURPOSE_
Anti-Gas
_USES_
relieves the symptoms of gas frequently caused by air swallowing or
certain formulas or foods
_WARNINGS_
WHEN USING THIS PRODUCT
do not exceed 12 doses per day
KEEP OUT OF REACH OF CHILDREN.
In case of accidental overdose, get medical help or contact a Poison
Control Center (1-800-222-1222)
immediately.
_DIRECTIONS_
SHAKE WELL BEFORE USING
all dosages may be repeated as needed, after meals and at bedtime
fill enclosed dropper to recommended dosage level
DOSE BY WEIGHT OR IF WEIGHT INFORMATION IS NOT AVAILABLE, DOSE BY AGE.
dispense liquid slowly into baby’s mouth, toward inner cheek
may mix with 1 oz. of cool water, infant formula or other suitable
liquids
clean dropper after each use and replace original cap
AGE (YR)
WEIGHT (LB)
DOS E
infants under 2
under 24
0.3 mL
children 2 and over
24 and over
0.6 mL
_OTHER INFORMATION_
Do not freeze
Store at room temperature 20-25ºC (68-77ºF)
See bottle or box for lot number and expiration date
_INACTIVE INGREDIENTS_
citric acid, flavor, microcrystalline cellulose, propylene glycol,
sodium benzoate, sodium
carboxymethylcellulose, sucralose, xanthan gum
_QUESTIONS OR COMMENTS?_
call 1-888-474-3099 Mon. – Fri. 8 am to 8 pm EST or visit us at
PEDIACARE.COM
PRINCIPAL DISPLAY PANEL
INFANTS 0-36 months
PediaCare
we care for kids
Gas Relief DROPS
SIMETHICONE-ANTI GAS
NON-STAINING
1 FL OZ (30 mL)
®
TM
PEDIACARE GAS RELIEF DROPS DYE FREE
simethicone emulsion and simethicone liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 30 29 -8 11
ROUTE OF ADMINISTRATION
ORAL
ACTIV