Active Ingredient (In Each Tablet)
Ranitidine 150 mg
(as ranitidine hydrochloride, USP 168 mg)
Regular Strength Acid Reducer
FDA Label NDC 55319-351
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar for the product Regular Strength Acid Reducer (NDC 55319-351). 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 tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acid reducer
Uses
- relieves heartburn associated with acid indigestion and sour stomach
- prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages
Warnings
Allergy alert: Do not use if you are allergic to ranitidine or any 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
- if you have kidney disease, except under the advice and supervision of a doctor
Ask A Doctor Before Use If You Have
- frequent chest pain
- frequent wheezing, particularly with heartburn
- unexplained weight loss
- nausea or vomiting
- stomach pain
- 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
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:
- to relieve symptoms, swallow 1 tablet with a glass of water
- to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutesbefore eating food or drinking beverages that cause heartburn
- can be used up to twice daily (do not take more than 2 tablets in 24 hours)
- children under 12 years: ask a doctor
Other Information
- TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER IS OPEN OR TORN
- store at 20° - 25°C (68° - 77°F)
- avoid excessive heat or humidity
- this product is sodium and sugar free
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, hyrpomellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide
Questions
call 1-800-406-7984
Principal Display Panel
FAMILY
wellness
COMPARE TO THE ACTIVE INGREDIENT OF ZANTAC 150*
Maximum Strength
Acid Reducer
Ranitidine Tablets, USP 150 mg
Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach
24 TABLETS
DISTRIBUTED BY
FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD,
MATTHEWS, NC 28105 USA
5110360 0614
MADE IN INDIA
Ranitidine_150mg_24's (Image 01)
Ranitidine_150mg_24's
* Please review the disclaimer below.
