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NDC 69842-0807-53 loperamide hydrochloride and simethicone 125; 2 mg/1; mg/1 Details
loperamide hydrochloride and simethicone 125; 2 mg/1; mg/1
loperamide hydrochloride and simethicone is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is DIMETHICONE; LOPERAMIDE HYDROCHLORIDE.
MedlinePlus Drug Summary
Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Loperamide is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel and by slowing down the movement of the bowel to decrease the number of bowel movements.
Related Packages: 69842-0807-53Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loperamide
Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 69842-0807-53Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone
Product Information
| NDC | 69842-0807 |
|---|---|
| Product ID | 69842-807_005cc87d-19ba-4fe3-aa68-a460e81b7d3a |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | loperamide hydrochloride and simethicone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | loperamide hydrochloride, simethicone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 125; 2 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DIMETHICONE; LOPERAMIDE HYDROCHLORIDE |
| Labeler Name | CVS Pharmacy |
| Pharmaceutical Class | Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209837 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69842-0807-53 (69842080753)
| NDC Package Code | 69842-807-53 |
|---|---|
| Billing NDC | 69842080753 |
| Package | 12 BLISTER PACK in 1 CARTON (69842-807-53) / 1 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2018-10-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |