Otc - Active Ingredient
Active ingredients
(in each 10 mL dose)
Calcium carbonate 800 mg
Simethicone Emulsion 266.6 mg/ Simethicone 80 mg
Mylanta Liquid
FDA Label NDC 85766-051
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sportpharm Llc for the product Mylanta (NDC 85766-051). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor/pharmacist, otc - keep out of reach of children, dosage & administration, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes
Antacid
Anti-gas
Indications & Usage
Usesrelieves:
• heartburn • acid indigestion • sour stomach
• upset stomach due to thse symptoms
• pressure and bloating commonly referred to as gas
• overindulgence in food and drink
Warnings
Warnings
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before useif you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Otc - 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.
Dosage & Administration
Directions
• shake well before use • measure with dosing cup provided
• take as needed, between meals, at bedtime or as directed by a doctor
• do not use the maximum dosage for more than 2 weeks
• follow directions based on age below
| Age | Dosage |
| children ages 6-11 yrs | 10 mL. Not to exceed more than 30 mL in 24 hours |
| adults and children 12 yrs of age and over | 10-20 mL. Not to exceed more than 60 mL in 24 hours |
• mL=milliliter
Other Information
• each 10 mL dose contains:
calcium 320 mg; sodium 5 mg
• store between 20-25°C (68-77°F), do not freeze
Inactive Ingredient
Inactive ingredients
benzyl alcohol, carboxymethylcellulose sodium, D&C red no. 28, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum
Otc - Questions
Questions or comments?call 1-844-695-6624
toll free (English and Spanish)
Other
Distributed by:
Sportpharm
2237 N Commerce Parkway,
STE 1, Weston, Florida-33326
Relabeled by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501
Package Label.Principal Display Panel
51 (Label 051)
* Please review the disclaimer below.
