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

Purpose

Antigas

Use

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)	Dose
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

pdp

SIMETHICONE
simethicone suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68071-4207(NDC:0536-2220)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MALTITOL (UNII: D65DG142WK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white (off-white)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68071-4207-1	30 mL in 1 BOX; Type 0: Not a Combination Product	12/29/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	12/01/2010	12/31/2019

Labeler - NuCare Pharmaceuticals,Inc. (010632300)

Name	Address	ID/FEI	Business Operations
Establishment
NuCare Pharmaceuticals,Inc.		010632300	relabel(68071-4207)

Revised: 6/2020

Document Id: a7bd415a-dc91-6c65-e053-2a95a90aba25

Set id: 61836028-d838-7e44-e053-2991aa0a1642

Version: 2

Effective Time: 20200610

NuCare Pharmaceuticals,Inc.