FDA Label for Mylanta All-family Multi Symptom Stomach Remedy
View Indications, Usage & Precautions
Mylanta All-family Multi Symptom Stomach Remedy Product Label
The following document was submitted to the FDA by the labeler of this product Infirst Healthcare Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients
(in each 10 mL dose)
Calcium carbonate 800 mg
Simethicone Emulsion 266.6 mg/ Simethicone 80 mg
Otc - Purpose
Purposes
Antacid
Anti-gas
Indications & Usage
Uses relieves:
• 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 use if 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
Great-tasting
All-Family Mylanta ®
QUICKLY SOOTHES for fast relief
MULTI-SYMPTOM RELIEF
of heartburn, gas, and upset stomachs
due to overindulgence in food and drink
GREAT-TASTING mixed berry flavor
ACTIVE INGREDIENTS:
CALCIUM CARBONATE, SIMETHICONE
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
infirst +™
Manufactured for:
Infirst Healthcare Inc.
Westport, CT 06880
2024 Infirst Healthcare Inc.
©Mylanta.com
Lot:
Exp:
Package Label.Principal Display Panel
VALUE SIZE
ALL-FAMILY
Mylanta ®
ANTACID+ANTI-GAS
MULTI-SYMPTOM
STOMACH REMEDY
Fast Relief of Heartburn,
Gas, and Upset Stomachs
for Adults & Children
Ages 6+
MIXED BERRY FLAVOR
16 FL OZ (473 mL)
* Please review the disclaimer below.
