EXTRA STRENGTH GAS RELIEF- simethicone liquid

EXTRA STRENGTH by

Drug Labeling and Warnings

EXTRA STRENGTH by is a Otc medication manufactured, distributed, or labeled by KRAMER LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each 5 mL)

Simethicone 125 mg

Purpose

Antigas

Uses

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 at 1-800-222-1222. Quick medical attention is critical even if you do not notice any sign or symptoms.

Directions

• ▪ shake well before using
• ▪ do not take more than 20 mL in any 24-hour period except under the advice and supervision of a physician
• ▪ measure only with dosing cup provided
• ▪ do not use dosing cup with other products
• ▪ mL = milliliter
• ▪ adults: 5 mL or 10 mL in dosing cup provided as needed after meals and at bedtime.

Other information

• ▪ Each 5 mL contains: sodium 2 mg
• ▪ store at 20° – 25°C (68° – 77°F )
• ▪ do not refrigerate
• ▪ protect from light, heat, and moisture

Inactive ingredients

carboxymethylcellulose sodium, citric acid anhydrous, flavor, glycerin, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, sucralose, xanthan gum.

Questions or comments?

Call 1-800-824-4894

Principal Display Panel

SAFE AND EFFECTIVE RELIEF

RELIEVES GAS FAST

NDC# 55505-225-36

Kaopectate®

Simethicone 125mg Anti-gas

Extra Strength

Gas Relief Liquid

• ✓ Pressure
• ✓ Bloating
• ✓ Discomfort

Starts to work in minutes

• Dye-free
• Sugar-free

Berry Flavor

48 DOSES

Dosage cup inside

8 FL OZ (237 mL)

IMPORTANT: Keep this carton for future reference on full labeling.

Distributed by

Kramer Laboratories, Inc.,

Bridgewater, NJ, 08807

1-800-824-4894

TAMPER EVIDENT: Do not use if foil seal under cap, printed with “SEALED FOR YOUR PROTECTION” is missing, open or broken.

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH  GAS RELIEF
simethicone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-225
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-225-36	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	08/26/2020

Labeler - KRAMER LABORATORIES (122720675)