Lil drug store anti-diarrheal tablet

Spl unclassified section

Drug Facts

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use

Controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

Allergy alert

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

Otc - do not use section

Do not useif you have bloody or black stool

Otc - ask doctor section

Ask a doctor before use if you have

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

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you aretaking antibiotics

Otc - when using section

When using this product

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

Otc - stop use section

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 section

If pregnant or breast-feeding,ask a health professional before use.

Otc - keep out of reach of children section

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 over 2 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 years do 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 68-77F (20-25C)
  • see bottom panel of carton or pouch for expiration date and lot number

Inactive ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow #10, FD&C Blue # 1, 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)

Ingredients and appearance - Product information

Lil drug store anti-diarrheal tablet- Loperamide hydrochloride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 66715-9754
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Loperamide hydrochloride ( UNII: 77TI35393C)( Loperamide - UNII: 6X9OC3H4II ) 2 mgin 1

Inactive Ingredients

Ingredient Name Code
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Croscarmellose sodium ( UNII: M28OL1HH48)
Crospovidone ( UNII: 68401960MK)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Magnesium stearate ( UNII: 70097M6I30)
Powdered cellulose ( UNII: SMD1X3XO9M)
Starch, corn ( UNII: O8232NY3SJ)

Product Characteristics

Color GREEN Score 1
Shape OVAL Size 10 mm
Imprint Code 123

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075232 USA

Labeler - Lil' Drug Store Products, Inc.( 093103646)

Principal display panel - 4 caplet pouch carton

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

Lil'
Drug Store ®

Anti-
Diarrheal
Loperamide HCl, 2 mg

Controls Symptoms
of Diarrhea

4 CAPLETS