Dimetapp Multi-symptom Cold And Flu
Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride
Foundation Consumer Brands
Human Otc Drug
NDC 80070-330Dimetapp Multi-symptom Cold And Flu also known as Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride is a human otc drug labeled by 'Foundation Consumer Brands'. National Drug Code (NDC) number for Dimetapp Multi-symptom Cold And Flu is 80070-330. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Dimetapp Multi-symptom Cold And Flu drug includes Acetaminophen - 320 mg/10mL Diphenhydramine Hydrochloride - 12.5 mg/10mL Phenylephrine Hydrochloride - 5 mg/10mL . The currest status of Dimetapp Multi-symptom Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 80070-330 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Dimetapp Multi-symptom Cold And Flu |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Dimetapp |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Multi-Symptom Cold and Flu |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Foundation Consumer Brands |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ACETAMINOPHEN - 320 mg/10mL
DIPHENHYDRAMINE HYDROCHLORIDE - 12.5 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE - 5 mg/10mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 15 Sep, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Foundation Consumer Brands
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1050385
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0850026660050
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
TC2D6JAD40
04JA59TNSJ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Adrenergic alpha1-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
alpha-1 Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 80070-330-04 | 1 BOTTLE in 1 CARTON (80070-330-04) / 118 mL in 1 BOTTLE | 15 Sep, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Active ingredients (in each 10 ml) purposes acetaminophen, 320 mg pain reliever/fever reducer diphenhydramine hcl, 12.5 mg antihistamine/cough suppressant phenylephrine hcl, 5 mg nasal decongestant
Product Elements:
Dimetapp multi-symptom cold and flu acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine anhydrous citric acid edetate disodium fd&c red no. 40 glycerin menthol, unspecified form polyethylene glycol, unspecified propyl gallate propylene glycol water sodium benzoate sodium citrate, unspecified form sorbitol sucralose
Indications and Usage:
Uses temporarily relieves these common cold and flu symptoms: minor aches and pains headache nasal congestion sore throat cough runny nose itching of the nose or throat sneezing temporarily reduces fever temporarily restores freer breathing through the nose
Warnings:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use to sedate a child or to make a child sleepy in a child under 6 years of age if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you d
Read more...o not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin ask a doctor before use if user has liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma 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 user is taking the blood thinning drug warfarin taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers when using this product do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with fever, rash or headache that lasts. 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. prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Do Not Use:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if adult takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use to sedate a child or to make a child sleepy in a child under 6 years of age if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin ask a doctor before use if user has liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma 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 user is taking the blood thinning drug warfarin taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers when using this product do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with fever, rash or headache that lasts. 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. prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
When Using:
When using this product do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Dosage and Administration:
Directions do not exceed recommended dosage. taking more than the recommended dose (overdose) may cause serious liver damage. measure only with dosage cup provided keep dosage cup with product ml = milliliter age dose adults and children 12 years and over 20 ml every 4 hours do not take more than 6 doses in any 24-hour period children 6 to 12 years 10 ml every 4 hours do not give more than 5 doses in any 24-hour period children under 6 years do not use
Stop Use:
Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with fever, rash or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel - 118 ml bottle carton children's dimetapp ® acetaminophen (pain reliever/fever reducer) diphenhydramine hcl (antihistamine/cough suppressant) phenylephrine hcl (nasal decongestant) pharmacist recommended multi- symptom cold & flu relieves + comforts: ? fever ? head & body aches ? cough ? stuffy, runny nose ? sneezing ? sore throat 6+ yrs 4 fl oz (118 ml) red grape flavor alcohol free principal display panel - 118 ml bottle carton
Further Questions:
Questions or comments? call 1-888-594-0828 weekdays 9 am to 5 pm est