Other
Drug Facts
Product distributed by: Lil' Drug Store Products, Inc.
9300 Earhart Lane SW, Cedar Rapids, IA 52404
Anti-diarrheal Tablet
FDA Label NDC 66715-6841
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 Anti-diarrheal (NDC 66715-6841). 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 other, active ingredient (in each caplet), purpose, uses, reye's syndrome, allergy alert, otc - do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Caplet)
Bismuth subsalicylate 262 mg
Purpose
Upset stomach reliever and anti-diarrheal
Uses
relieves:
- indigestion
- nausea
- heartburn
- diarrhea
- upset stomach associated with these symptoms
Reye's Syndrome
Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy Alert
Contains salicylate. Do not take if you are
- allergic to salicylates (including aspirin)
- taking other salicylate products
Otc - Do Not Use
Do not use if you have
- bloody or black stool
- an ulcer
- a bleeding problem
Otc - Ask Doctor
Ask a doctor before use if you have
- fever
- mucus in the stool
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning of the blood)
- diabetes
- gout
- arthritis
Otc - When Using
When using this product a temporary, but harmless darkening of the stool and/or tongue may occur.
Stop Use And Ask A Doctor If
- symptoms get worse
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 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 immediately.
Directions
- swallow caplet(s) with water, do not chew
- adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
- do not take more than 8 doses (16 caplets) in 24 hours
- use until diarrhea stops but not more than 2 days
- children under 12 years: ask a doctor
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Other Information
- each caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg
- very low sodium
- store at 59°-77°F (15°-25°C), in a dry place
Inactive Ingredients
calcium carbonate, colloidal silicon dioxide, D&C red 27 lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate
Questions Or Comments?
call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)
Principal Display Panel - 262 Mg Caplet Bottle Carton
QUALITY
⋆ GUARANTEED ⋆
Anti-
Diarrheal
Bismuth subsalicylate 262 mg
Upset Stomach Reliever/
Anti-diarrheal
- Relieves the Symptoms
of Diarrhea
ACTUAL SIZE
24
Caplets
Lil'
Drug Store®
Principal Display Panel (262 mg Caplet Bottle Carton)
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