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NDC 51660-0069-06 Loperamide HCl and Simethicone 125; 2 mg/1; mg/1 Details
Loperamide HCl and Simethicone 125; 2 mg/1; mg/1
Loperamide HCl and Simethicone is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Ohm Laboratories Inc.. 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: 51660-0069-06Last Updated: 11/30/2022
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: 51660-0069-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone
Product Information
| NDC | 51660-0069 |
|---|---|
| Product ID | 51660-069_86ddd92a-920c-40b8-b0bd-29bfb3b38bfc |
| 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 HCl and Simethicone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Loperamide HCl and 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 | Ohm Laboratories Inc. |
| Pharmaceutical Class | Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077500 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51660-0069-06 (51660006906)
| NDC Package Code | 51660-069-06 |
|---|---|
| Billing NDC | 51660006906 |
| Package | 6 TABLET in 1 BLISTER PACK (51660-069-06) |
| Marketing Start Date | 2022-01-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 06f99f59-e702-49f1-bb1d-e7cf58c54c30 Details
Warnings
Allergy alert:
Do not use if you have ever had a rash or other allergic reaction to loperamide HCl
Heart Alert: Taking more than directed can cause serious heart problems or death
Ask a doctor before use if you have
- •
- fever
- •
- mucus in the stool
- •
- a history of liver disease
- •
- a history of abnormal heart rhythm
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Loperamide may interact with certain prescription drugs.
When using this product
tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Directions
- •
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- •
- take only on an empty stomach (1 hour before or 2 hours after a meal)
- •
- take with a full (8 oz.) glass of water
- •
- find right dose on chart below. 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 2-5 years (34 to 47 lbs) |
ask a doctor |
|
children under 2 years (upto 33 lbs) |
do not use |
Inactive ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton
INGREDIENTS AND APPEARANCE
| LOPERAMIDE HCL AND SIMETHICONE
loperamide hcl and simethicone tablet |
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| Labeler - Ohm Laboratories Inc. (184769029) |
| Registrant - Sun Pharmaceutical Industries, Inc. (146974886) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | 650456002 | MANUFACTURE(51660-069) | |