SIMETHICONE- simethicone suspension/ drops

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Fáanlegur frá:

NuCare Pharmaceuticals,Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

OTC DRUG

Ábendingar:

Antigas relieves the symptoms referred to as gas

Leyfisstaða:

OTC monograph final

Vara einkenni

SIMETHICONE- SIMETHICONE SUSPENSION/ DROPS
NUCARE PHARMACEUTICALS,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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RUGBY INFANT DROPS
ACTIVE INGREDIENT (IN EACH 0.3 ML)
Simethicone 20 mg
PURPOS E
Antigas
US E
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 inner cheek
may be mixed with 1 oz of water, infant formula or other suitable
liquid
for best results, clean dropper after each use and replace original
cap
AGE (YEARS)
WEIGHT (LBS)
DOS E
infants (under 2)
under 24
0.3 mL
children (over 2)
over 24
0.6 mL
OTHER INFORMATION
store at room temperature
do not freeze
see bottom panel for lot number and expiration date
TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP IS BROKEN OR MISSING
INACTIVE INGREDIENTS
carboxymethylcellulose sodium, citric acid, flavor, maltitol,
microcrystalline cellulose, purified water,
sodium benzoate, sodium citrate, xanthan gum.
QUESTIONS OR COMMENTS?
1-800-645-2158
PACKAGE LABEL
SIMETHICONE
simethicone suspension/ drops
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 0 71-420 7(NDC:0 536 -2220 )
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)
DIMETHICONE
20 mg in 0 .3 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)
ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)
MALTITO L (UNII: D6 5DG142WK)
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6