CAREONE EXTRA STRENGTH GAS RELIEF - simethicone tablet, chewable
Retail Business Services, LLC.

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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Extra Strength Gas Relief Tablets

ACTIVE INGREDIENT(in each tablet)

Simethicone 125 mg

PURPOSE

Anti-gas

USE(S)

relieves:

pressure
bloating
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 immediately.

DIRECTIONS

chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

OTHER INFORMATION

do not use if any individual blister unit is broken or open
store at room temperature
avoid high humidity and excessive heat, above 40ºC (104ºF)

INACTIVE INGREDIENTS

D&C red # 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

PRINCIPAL DISPLAY PANEL

NDC 72476-019-73

Careone

Compare to the Active Ingredient in Gas-X® Chewables Extra Strength*
EXTRA STRENGTH
GAS RELIEF
Simethicone 125 mg - Anti-Gas

Cherry Creme
FAST RELIEF OF:

DISCOMFORT FROM GAS
BLOATING
PRESSURE

18 chewable tablets
102

CAREONE EXTRA STRENGTH GAS RELIEF
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72476-019
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 30 (UNII: 2S42T2808B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	14mm
Flavor	CHERRY	Imprint Code	G134
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72476-019-73	3 in 1 CARTON	10/13/2021
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part332	10/13/2021

Labeler - Retail Business Services, LLC. (967989935)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	MANUFACTURE(72476-019)