NDC 80070-330 Dimetapp Multi-symptom Cold And Flu

Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride

NDC Product Code 80070-330

NDC CODE: 80070-330

Proprietary Name: Dimetapp Multi-symptom Cold And Flu What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Diphenhydramine Hydrochloride, And Phenylephrine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
RED (C48326)
Flavor(s):
GRAPE (C73391)

NDC Code Structure

  • 80070 - Foundation Consumer Brands

NDC 80070-330-04

Package Description: 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE

NDC Product Information

Dimetapp Multi-symptom Cold And Flu with NDC 80070-330 is a a human over the counter drug product labeled by Foundation Consumer Brands. The generic name of Dimetapp Multi-symptom Cold And Flu is acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride. The product's dosage form is solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1050385.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Dimetapp Multi-symptom Cold And Flu Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Foundation Consumer Brands
Labeler Code: 80070
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-15-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Dimetapp Multi-symptom Cold And Flu Product Label Images

Dimetapp Multi-symptom Cold And Flu Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

  • Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.

Distributed by:Foundation Consumer Brands, LLCPittsburgh, PA 15212

Otc - Purpose

Active ingredients (in each 10 mL)PurposesAcetaminophen, 320 mgPain reliever/fever reducerDiphenhydramine HCl, 12.5 mgAntihistamine/cough suppressantPhenylephrine HCl, 5 mgNasal decongestant

Uses

  • Temporarily relieves these common cold and flu symptoms:minor aches and painsheadachenasal congestionsore throatcoughrunny noseitching of the nose or throatsneezingtemporarily reduces fevertemporarily restores freer breathing through the nose

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur ifadult takes more than 6 doses in 24 hours, which is the maximum daily amountchild takes more than 5 doses in 24 hourstaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks every day while using this product.

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 sleepyin a child under 6 years of ageif 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 diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandglaucomacough 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 warfarintaking any other oral nasal decongestant or stimulanttaking sedatives or tranquilizers

When Using This Product

  • Do not use more than directedmay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in children

Stop Use And Ask A Doctor If

  • Nervousness, dizziness or sleeplessness occurspain, 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 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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.

Directions

  • Do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.measure only with dosage cup providedkeep dosage cup with productmL = milliliteragedoseadults and children 12 years and over20 mL every 4 hours do not take more than 6 doses in any 24-hour periodchildren 6 to 12 years10 mL every 4 hours do not give more than 5 doses in any 24-hour periodchildren under 6 yearsdo not use

Other Information

  • Each 10 mL contains: sodium 7 mg and potassium 6 mgstore at 20-25°C (68-77°F)read and keep carton

Inactive Ingredients

Anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

* Please review the disclaimer below.