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| Product NDC Code | 69536-370 | ||||
|---|---|---|---|---|---|
| Drug Name | Dimetapp cough and allergy |
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| Type | Brand | ||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 1049900 | ||||
| Application Number | M012 | ||||
| Labeler Name | Foundation Consumer Healthcare | ||||
| 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.Diphenhydramine HCl 12.5 mg Active ingredients (in each chewable tablet) Purposes Diphenhydramine HCl 12.5 mg Antihistamine/Cough suppresant
| Diphenhydramine HCl 12.5 mg | Antihistamine/Cough suppresant |
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 chew or crush tablets completely before swallowing, do not swallow tablets whole do not take more than 6 doses in 24 hours age dose adults and children 12 years and over take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours children 6 to under 12 years take 1 tablet every 4 hours not to exceed 6 tablets in 24 hours children under 6 years do not use
| age | dose |
| adults and children 12 years and over | take 2 tablets every 4 hours not to exceed 12 tablets in 24 hours |
| children 6 to under 12 years | take 1 tablet every 4 hours not to exceed 6 tablets in 24 hours |
| children under 6 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients D&C red no.27 aluminum lake, D&C red no.30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue no.1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, modified corn starch, stearic acid, sucralose, sucrose
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.Uses temporarily relieves: cough runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily alleviates the intensity of coughing
Purpose
Information about the drug product’s indications for use.Active ingredients (in each chewable tablet) Purposes Diphenhydramine HCl 12.5 mg Antihistamine/Cough suppresant
| Diphenhydramine HCl 12.5 mg | Antihistamine/Cough suppresant |
Spl product data elements
Usually a list of ingredients in a drug product.Dimetapp Cough and Allergy DIPHENHYDRAMINE HYDROCHLORIDE FD&C BLUE NO. 1 ALUMINUM LAKE MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) SUCRALOSE SUCROSE D&C RED NO. 30 MAGNESIUM STEARATE D&C RED NO. 27 ALUMINUM LAKE DEXTRATES ETHYLCELLULOSE, UNSPECIFIED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MANNITOL STEARIC ACID DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE DT
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 - 24 ct Carton CHILDREN'S Dimetapp DIPHENHYDRAMINE HCl, 12.5 mg (Antihistamine/Cough Suppressant) GREAT CHEWABLE TASTE Cough & Allergy Relieves + comforts: Cough Itchy throat Sneezing Runny nose 6+ years 24 CHEWABLE TABLETS Grape-Flavored Dimetapp - 24ct Carton
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.Drug Facts
Distributed by: Foundation Consumer Healthcare, LLC Pittsburgh, PA 15212
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 glaucoma trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 sedatives or tranquilizers
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 to sedate a child or make a child sleepy with any other product containing diphenhydramine, even one used on skin
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at 20-25°C (68-77°F) avoid high humidity
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 1-888-594-0828 weekdays 9 AM to 5PM EST
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 cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could 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 may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a vehicle or operating machinery excitability may occur, expecially in children
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use.
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 Do not use to sedate a child or make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a vehicle or operating machinery excitability may occur, expecially in children Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could 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