NDC 61787-516 Diabetic Tussin Nighttime Cold And Flu

Acetaminophen, Dextromethorphan Hbr, And Diphenhydramine Hcl

NDC Product Code 61787-516

NDC 61787-516-04

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

NDC Product Information

Diabetic Tussin Nighttime Cold And Flu with NDC 61787-516 is a a human over the counter drug product labeled by Akorn Consumer Health. The generic name of Diabetic Tussin Nighttime Cold And Flu is acetaminophen, dextromethorphan hbr, and diphenhydramine hcl. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Akorn Consumer Health

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Diabetic Tussin Nighttime 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.

  • ACETAMINOPHEN 650 mg/10mL
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/10mL

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.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • RASPBERRY (UNII: 4N14V5R27W)
  • WATER (UNII: 059QF0KO0R)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

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.
  • 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: Akorn Consumer Health
Labeler Code: 61787
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-01-2020 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Diabetic Tussin Nighttime Cold And Flu Product Label Images

Diabetic Tussin Nighttime 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

Active Ingredients (In Each 10 Ml)

Acetaminophen 650 mgDextromethorphan HBr 20 mgDiphenhydramine HCl 25 mg

Purposes

Pain ReliefCough SuppressantAntihistamine

Uses

  • Temporarily relieves common cold/flu symptoms including: •cough due to minor throat and bronchial irritation •sore throat •headache •minor aches and pains •muscular aches •fever •runny nose and sneezing

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if •adults take more than 6 doses in 24 hours, which is the maximum daily amount •child takes more than 5 doses in 24 hours, which is the maximum daily amount •taken with other drugs containing acetaminophen •adult has 3 or more alcoholic drinks everyday while using this productSore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. •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 product containing diphenhydramine, even one used on the skin

Ask A Doctor Before Use If You Have

  • •liver disease •glaucoma •a breathing problem such as emphysema or chronic bronchitis •trouble urinating due to enlargement of the prostate gland •cough that occurs with too much phlegm (mucus) •a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask A Doctor Or Pharmacist Before Use

If the user is taking the blood thinning drug warfarin, tranquilizers or sedatives.

When Using This Product:

  • •you may get very drowsy •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 small children

Stop Use And Ask A Doctor If

  • •redness or swelling is present •fever gets worse or lasts more than 3 days •new symptoms occur •pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) •cough comes back or occurs with rash or headache that lastsThese 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 even if you do not notice any signs or symptoms.

Directions

  • •take every 4 to 6 hours •do not exceed more than 6 doses in 24 hours for adults and children over 12 years of ageAdults10 mL (2 teaspoons)Children under 12 yearsask a doctor

Other Information

  • •Store at room temperature 20-25°C (68-77°F)

Inactive Ingredients

Acesulfame potassium, artificial raspberry flavor, hypromellose, menthol, methylparaben, polyethylene glycol, potassium sorbate, propylene glycol, purified water, and sucralose. Citric acid may be used to adjust pH.

* Please review the disclaimer below.