Active Ingredient (In Each 5 Ml)
Simethicone 125 mg
Extra Strength Liquid
FDA Label NDC 55505-225
10 label sections · Submitted to the FDA by Kramer Laboratories · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Extra Strength (NDC 55505-225). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, if pregnant or breast-feeding,, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Uses
for the relief of pressure, bloating, and fullness commonly referred to as gas
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- Dye-free
- Sugar-free
Starts to work in minutes
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.
* Please review the disclaimer below.
