FDA Label for Lil Drug Store Anti-diarrheal

View Indications, Usage & Precautions

Lil Drug Store Anti-diarrheal Product Label

The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, Inc.. 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.

Other



Drug Facts


Active Ingredient (In Each Caplet)



Loperamide HCl, USP 2 mg


Purpose



Anti-diarrheal


Use



Controls symptoms of diarrhea, including Travelers' Diarrhea


Allergy Alert



Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.


Otc - Do Not Use



Do not use if you have bloody or black stool


Ask A Doctor Before Use If You Have



  • fever
  • mucus in the stool
  • a history of liver disease

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking antibiotics


When Using This Product



  • tiredness, drowsiness or dizziness may occur
  • be careful when driving or operating machinery

Stop Use And Ask A Doctor If



  • symptoms get worse
  • diarrhea lasts for more than 2 days
  • you get abdominal swelling or bulging. These may be signs of a serious condition.

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



  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • do not take more than directed
  • adults and children 12 years and over2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
    children under 12 yearsdo not use this product for children under 12 years of age

Other Information



  • do not use if carton or inner pouch is open or torn
  • store between 68-77°F (20-25°C)
  • see bottom panel of carton or pouch for expiration date and lot number

Inactive Ingredients



anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow no. 10 aluminum lake, FD&C Blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch


Questions Or Comments?



call toll-free 1-877-507-6516 (M-F 8AM – 4:30PM CST)


Principal Display Panel - 2 Mg Caplet Pouch Carton



QUALITY
⋆ GUARANTEED ⋆

Compare to the Active
Ingredient in Imodium® A-D*

Anti-
Diarrheal
on
the
Go
PACKS

Anti-Diarrheal

Loperamide HCl Tablets, USP 2 mg

Controls the Symptoms of Diarrhea

4
Caplets
2 POUCHES, 2 CAPLETS PER POUCH

Lil'
Drug Store®


* Please review the disclaimer below.