HEB GAS RELIEF EXTRA STRENGTH PEPPERMINT - simethicone tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
H E B
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-gas relieves: - pressure - bloating - symptoms referred to as gas
Authorization status:
OTC monograph final
Authorization number:
37808-155-73

HEB GAS RELIEF EXTRA STRENGTH PEPPERMINT - simethicone tablet, chewable

H E B

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.

----------

HEB 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, D&C yellow # 10 aluminum lake, dextrose, flavor, magnesium stearate,

maltodextrin, microcrystalline cellulose, sorbitol, sucrose

PRINCIPAL DISPLAY PANEL

*Compare to Gas-X® EX chewables active ingredient

NDC 37808-155-73

HEB

Extra strength

Gas

Relief

Simethicone 125 mg

Anti-Gas

Fast Relief of:

Symptoms Referred to as Gas

Dis comfort

Pres s ure

Bloating

Peppermint Flavor

18 chewable tablets

HEB GAS RELIEF EXTRA STRENGTH PEPPERMINT

simethicone tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:378 0 8 -155

Route of Administration

ORAL

H E B

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

125 mg

Inactive Ingredients

Ingredient Name

Stre ng th

D&C RED NO . 3 0 (UNII: 2S42T28 0 8 B)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRO SE (UNII: C151H8 M554)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

DEXTRO SE, UNSPECIFIED FO RM (UNII: IY9 XDZ35W2)

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

ROUND

S iz e

14mm

Flavor

PEPPERMINT

Imprint Code

G134

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:378 0 8 -155-73

2 in 1 CARTON

0 9 /28 /20 18

1

9 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt332

0 9 /28 /20 18

Labeler -

H E B (007924756)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Guardian Drug Co mpany

119 210 276

MANUFACTURE(378 0 8 -155)

Revised: 9/2018

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