NDC 61787-452 Diabetic Tussin Nighttime Cold And Flu

NDC Product Code 61787-452

NDC CODE: 61787-452

Proprietary Name: Diabetic Tussin Nighttime 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.

Product Characteristics

Color(s):
BROWN (C48332 - CLEAR, COLORLESS TO LIGHT BROWN)
Flavor(s):
ORANGE (C73406 - NATURAL & ARTIFICIAL ORANGE FLAVOR)
MENTHOL (C73403)

NDC Code Structure

NDC 61787-452-04

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

NDC 61787-452-08

Package Description: 1 BOTTLE in 1 CARTON > 237 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Diabetic Tussin Nighttime Cold And Flu with NDC 61787-452 is a product labeled by Health Care Products. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1094131.

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.

  • WATER (UNII: 059QF0KO0R)
  • ASPARTAME (UNII: Z0H242BBR1)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Labeler Information

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

Labeler Name: Health Care Products
Labeler Code: 61787
Start Marketing Date: 08-01-2010 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)
Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]

* 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 5 Ml)

Acetaminophen 325 mgDextromethorphan HBr 10 mgDiphenhydramine HCl 12.5 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 •cough lasts more than 7 days, comes back, or occurs with fever, 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 5 doses in 24 hours for children under 12 years of age •do not exceed more than 6 doses in 24 hours for adults and children over 12 years of ageadults & children 12 years & over10 mL (2 teaspoonfuls)children 6 years to under 12 years5 mL (1 teaspoonful)children under 6 yearsask a doctor

Other Information

  • •Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL) •Store at room temperature 20-25°C (68-77°F)

Inactive Ingredients

Acesulfame potassium, aspartame, citric acid, hypromellose, menthol, methylparaben, natural & artificial orange flavor, polyethylene glycol, potassium sorbate, propylene glycol, purified water. Sodium citrate may be used to adjust pH.

* Please review the disclaimer below.