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| Product NDC Code | 63187-462 | ||||
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| 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 | TABLET | ||||
| RxCUI drug identifier | 978010 | ||||
| Application Number | ANDA074091 | ||||
| Labeler Name | Proficient Rx LP | ||||
| 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 HCl USP, 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; ½ 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; ½ 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch
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(S) 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.Loperamide Hydrochloride Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE LOPERAMIDE CROSCARMELLOSE SODIUM CROSPOVIDONE (120 .MU.M) D&C YELLOW NO. 10 FD&C BLUE NO. 1 MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, CORN GLYCERYL TRISTEARATE ANHYDROUS LACTOSE 123
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 NDC 63187-462-12 Loperamide HCl Tablets, USP 2 mg Anti-Diarrheal 12 CAPLETS † Each caplet( † capsule-shaped tablet) contains Loperamide HCl, USP 2 mg Controls The Symptoms of Diarrhea * Compare to the active ingredient of Imodium ® A-D * This product is not manufactured or distributed by McNeil-PPC, distributor of Imodium ® A-D . Imodium ® is a registered trademark of Johnson & Johnson. 63187-462-12
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.QUESTIONS? call 1800-406-7984 Keep the carton. It contains important information. Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320
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 • diarrhea lasts for more than 2 days • symptoms get worse • 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 • store between 20° – 25° C (68° – 77° F) • see side panel for lot number and expiration date • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.
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 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 • 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 (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