Active Ingredients (In Each Chewable Tablet)
Famotidine 10 mg
Calcium carbonate 800 mg
Magnesium hydroxide 165 mg
Equaline Complete Tablet, Chewable
FDA Label NDC 41163-321
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Equaline Complete (NDC 41163-321). 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 ingredients (in each chewable tablet), purposes, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Acid reducer
Antacid
Use
relieves heartburn associated with acid indigestion and sour stomach
Warnings
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Do Not Use
- if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
- with other acid reducers
Ask A Doctor Before Use If You Have
- had heartburn over 3 months. This may be a sign of a more serious condition.
- heartburn with lightheadedness, sweating, or dizziness
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- frequent chest pain
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
- kidney disease
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.
Stop Use And Ask A Doctor If
- your heartburn continues or worsens
- you need to take this product for more than 14 days
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. (1-800-222-1222)
Directions
- adults and children 12 years and over:
- do not swallow tablet whole: chew completely
- to relieve symptoms, chew 1 tablet before swallowing
- do not use more than 2 chewable tablets in 24 hours
- children under 12 years: ask a doctor
Other Information
- each tablet contains: calcium 330 mg; magnesium 80 mg
- Phenylketonurics: Contains Phenylalanine 2 mg per tablet
- read the directions and warnings before use
- read the bottle. It contains important information.
- store at 20-25°C (68-77°F)
- protect from moisture
Inactive Ingredients
anhydrous lactose, artificial berry flavor, aspartame, D&C red no. 7 calcium lake, dextrates, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, talc
Questions Or Comments?
1-855-423-2630
Principal Display Panel
compare to Pepcid Complete® active ingredients
dual action complete
famotidine 10mg, calcium carbonate 800mg, magnesium hydroxide 165mg tablets (chewable)
(acid reducer + antacid)
just one tablet relieves heartburn due to acid indigestion
SEE NEW WARNINGS
berry flavor
actual size
25 chewable tablets
321-el-dual-action-complete.jpg (321 El Dual Action Complete)
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