FDA Label for Maximum Strength Acid Controller
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Maximum Strength Acid Controller Product Label
The following document was submitted to the FDA by the labeler of this product Better Living Brands Llc.. 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 ingredient (in each tablet)
Famotidine USP 20 mg
Otc - Purpose
Purpose
Acid reducer
Indications & Usage
Uses
- relieves heartburn associated with acid indigestion and sour stomach
- prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Warnings
Warnings
Allergy alert: Do not use if you are allergic to famotidine or other acid reducers
Otc - Do Not Use
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
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Otc - Stop Use
Stop use and ask a doctor if
- your heartburn continues or worsens
- you need to take this product for more than 14 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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 (1-800-222-1222) right away
Dosage & Administration
Directions
adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
- do not use more than 2 tablets in 24 hours
children under 12 years: ask a doctor
Other Safety Information
Other information
- read the directions and warnings before use
- keep the carton. It contains important information.
- store at 20°-25°C (68°-77°F)
- protect from moisture
- The FDA approved dissolution methods differ from USP
Inactive Ingredient
Inactive ingredients carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide
Otc - Questions
Questions or comments? Call 1-877-290-4008
Package Label.Principal Display Panel
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