EXTRA STRENGTH GAS RELIEF- simethicone tablet, chewable

EXTRA STRENGTH GAS RELIEF by

Drug Labeling and Warnings

EXTRA STRENGTH GAS RELIEF by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceuticals, Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults: chew 1 or 2 tablets as needed after meals and at bedtime
• do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician

Other information

• each tablet contains: calcium 89 mg
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
• store at controlled room temperature
• protect from moisture

Inactive ingredients

cherry flavor, D&C red #27 lake, D&C red #30 lake, dextrates, FD&C red #40 lake, silica gel, sorbitol, starch, stearic acid, talc, tri-calcium phosphate

package label

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH GAS RELIEF 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-691
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TALC (UNII: 7SEV7J4R1U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
DEXTRATES (UNII: G263MI44RU)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)

Product Characteristics
Color	pink	Score	2 pieces
Shape	ROUND	Size	14mm
Flavor	CHERRY	Imprint Code	44;608
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-691-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	11/01/2015

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Registrant - Geri-Care Pharmaceuticals, Corp (611196254)