Kaopectate Extra Strength Gas Relief Liquid

Kaopectate Extra Strength Gas Relief Liquid
SPL v4
SPL
SPL Set ID d45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb
Route
ORAL
Published
Effective Date 2023-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Anhydrous Citric Acid Glycerin Microcrystalline Cellulose Polysorbate 60 Potassium Sorbate Water Sodium Benzoate Sorbitan Monostearate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-26

Description

Simethicone 125 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Uses

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

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.

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.

Active Ingredient (in Each 5 Ml)

Simethicone 125 mg


Structured Label Content

Uses

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

Purpose

Antigas

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 (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 (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? (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Active Ingredient (in Each 5 Ml) (Active Ingredient (in each 5 mL))

Simethicone 125 mg


Advanced Ingredient Data


Raw Label Data

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