Active Ingredients (In Each Chewable Tablet)
Famotidine 10 mg
Calcium carbonate 800 mg
Magnesium hydroxide 165 mg
Pepcid Complete, Travel Basix Tablet, Chewable
FDA Label NDC 66715-6522
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Pepcid Complete, Travel Basix (NDC 66715-6522). 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, allergy alert:, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, 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
Antacid
Use
- relieves heartburn associated with acid indigestion and sour stomach
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
Otc - Ask Doctor/Pharmacist
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
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 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 320 mg, magnesium 70 mg
- 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
- do not use if pouch is torn or damaged
Inactive Ingredients
cellulose acetate, corn starch, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, modified starch, sucralose
Questions Or Comments?
1-800-755-4008 (toll-free) or 215-273-8755 (collect)
Package Label.Principal Display Panel
DUAL ACTION
Pepcid ®
Complete
Famotidine 10mg - Acid Reducer
Calcium carbonate 800mg - Antacid
Magnesium Hydroxide 165mg - Antacid
Just One Tablet!
Relieves Heartburn Due
to Acid Indigestion
Berry Flavor
2
Chewable
Tablets [Lil' Drug Store logo]
DUAL ACTION
Pepcid®
Complete
Famotidine 10mg - Acid Reducer
Calcium carbonate 800mg - Antacid
Magnesium Hydroxide 165mg - Antacid
Just One Tablet!
Relieves Heartburn Due
to Acid Indigestion
Berry Flavor
5
Chewable
Tablets [Lil' Drug Store logo]
* Please review the disclaimer below.
