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| Product NDC Code | 80136-381 | ||||
|---|---|---|---|---|---|
| Drug Name | Anti-diarrheal |
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| Type | Brand | ||||
| Pharm Class | Opioid Agonist [EPC], Opioid Agonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 978010 | ||||
| Application Number | ANDA076497 | ||||
| Labeler Name | Northeast Pharma | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient(in each caplet) Loperamide HCI 2 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions 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 2-5 years (34-47 lbs) ask a doctor children under 2 years(up to 33 lbs) do not use
| 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 (34-47 lbs) | ask a doctor |
| children under 2 years(up to 33 lbs) | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients corn starch, D&C yellow #10 lake, dibasic calcium phosphate dihydrate, FD&C blue #1 lake, magnesium stearate, microcrystalline cellulose, silicon dioxide Questions or comments? call 1-800-540-3765
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use controls symptoms of diarrhea, including Travelers' Diarrhea
Purpose
Information about the drug product’s indications for use.Purpose Anti-diarrheal
Spl product data elements
Usually a list of ingredients in a drug product.Anti-Diarrheal Loperamide HCl DIBASIC CALCIUM PHOSPHATE DIHYDRATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN D&C YELLOW NO. 10 FD&C BLUE NO. 1 MAGNESIUM STEARATE SILICON DIOXIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE 44;375 light green
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.package Label 1
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call 1-800-540-3765
Storage and handling
Information about safe storage and handling of the drug product.Other Information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store between 20°-25°C (68°-77°F) see end flap for expiration date and lot number
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI Heart alert: Taking more than directed can cause serious heart problems or death. Do not use if you have bloody or black stool Ask a doctor before use if you have a fever mucus present in your 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. Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API