Label: DG HEALTH ANTI DIARRHEAL- loperamide hydrochloride tablet, film coated
- NDC Code(s): 55910-224-23, 55910-224-67
- Packager: Dolgencorp, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each caplet)
Loperamide HCl 2 mgClose
controls symptoms of diarrhea, including Travelers’ DiarrheaClose
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl
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.
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)
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- find right dose on chart. If possible, use weight to dose; otherwise, use age.
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 9-11 years (60-95 lbs)
1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)
1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs)
ask a doctor
- Other information
- store at 20°-25°C (68°-77°F)
- do not use if printed foil under cap is broken or missing
- see end panel for lot number and expiration date
- Inactive ingredients
anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starchClose
- Questions or comments?
- Principal Display Panel
Loperamide Hydrochloride Tablets, 2 mg
Compare to active ingredient if Imodium® A-D
Controls the Symptoms of Diarrhea
*Each Caplet (capsule-shaped tablet) Contains 2 mg Loperamide HydrochlorideClose
- INGREDIENTS AND APPEARANCE
DG HEALTH ANTI DIARRHEAL
loperamide hydrochloride tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-224 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Product Characteristics Color GREEN Score 2 pieces Shape CAPSULE Size 10mm Flavor Imprint Code L2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-224-67 1 in 1 CARTON 1 48 in 1 BOTTLE 2 NDC:55910-224-23 1 in 1 CARTON 2 72 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075232 12/28/2009 Labeler - Dolgencorp, LLC (068331990)