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| Product NDC Code | 68094-129 | ||||
|---|---|---|---|---|---|
| Drug Name | Loperamide hydrochloride |
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| Type | Generic | ||||
| Pharm Class | Opioid Agonist [EPC], Opioid Agonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 1250685 | ||||
| Application Number | ANDA091292 | ||||
| Labeler Name | Precision Dose, Inc. | ||||
| 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 7.5 mL) Loperamide HCl 1 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 Use as directed per healthcare professional. 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. shake well before using mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use
| adults and children 12 years and over | 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours |
| children 9-11 years (60-95 lbs) | 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours |
| children 6-8 years (48-59 lbs) | 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours |
| children 2-5 years (34 to 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 anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum
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 Read complete directions and warnings before using.
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.Loperamide Hydrochloride Loperamide Hydrochloride Loperamide Hydrochloride Loperamide anhydrous citric acid carboxymethylcellulose sodium, unspecified D&C Yellow No. 10 FD&C Blue No. 1 Glycerin Microcrystalline cellulose propylene glycol water sodium benzoate sucralose titanium dioxide xanthan gum dimethicone silicon dioxide opaque, viscous
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.PRINCIPAL DISPLAY PANEL - 2 mg/15 mL Cup Lid Label NDC 68094-129-59 PrecisionDose™ LOPERAMIDE Hydrochloride Oral SOLUTION 2 mg/15 mL Shake Well Delivers 15 mL Gluten Free Contains 7.5 mg Sodium Hospital Use Only Store at 20°-25°C (68°-77°F) Pkg. By: Precision Dose, Inc. S. Beloit, IL 61080 1253 R1 PRINCIPAL DISPLAY PANEL - 2 mg/15 mL Cup Lid Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Mint Flavor 1 mg/7.5 mL 2 mg/15 mL For Hospital Use Only
Drug Facts
Gluten Free
How Supplied NDC 68094-029-62 7.5 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-129-62 15 mL per unit dose cup Thirty (30) cups per shipper
Distributed By Perrigo Company Allegan, MI 49010 Packaged By Precision Dose, Inc. South Beloit, IL 61080
LI1251 Rev. 04/22
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have fever mucus in the stool a history of liver disease
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking antibiotics
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have bloody or black stool
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. (1-800-222-1222)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information each 30 mL contains: sodium 15 mg store between 20-25°C (68-77°F)
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 HCl 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 fever mucus in the stool a history of liver disease Ask a doctor or pharmacist before use if you are taking antibiotics 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. 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. (1-800-222-1222)
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