NDC 0067-8112 Triaminic Day Time Cold And Cough And Night Time Cold And Cough

Dextromethorphan Hbr, Phenylephrine Hcl And Diphenhydramine Hcl, Phenylephrine Hcl

NDC Product Code 0067-8112

NDC CODE: 0067-8112

Proprietary Name: Triaminic Day Time Cold And Cough And Night Time Cold And Cough 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: Dextromethorphan Hbr, Phenylephrine Hcl And Diphenhydramine Hcl, Phenylephrine Hcl 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.

NDC Code Structure

  • 0067 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc

NDC 0067-8112-08

Package Description: 1 KIT in 1 CARTON * 118 mL in 1 BOTTLE, PLASTIC (0067-8105-04) * 118 mL in 1 BOTTLE (0067-8106-04)

NDC Product Information

Triaminic Day Time Cold And Cough And Night Time Cold And Cough with NDC 0067-8112 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Triaminic Day Time Cold And Cough And Night Time Cold And Cough is dextromethorphan hbr, phenylephrine hcl and diphenhydramine hcl, phenylephrine hcl. The product's dosage form is kit and is administered via form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MALTITOL (UNII: D65DG142WK)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MALTITOL (UNII: D65DG142WK)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Labeler Information

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

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0067
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: 01-01-2016 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.

Triaminic Day Time Cold And Cough And Night Time Cold And Cough Product Label Images

Triaminic Day Time Cold And Cough And Night Time Cold And Cough 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)

Dextromethorphan HBr 5 mgPhenylephrine HCl 2.5 mg

Diphenhydramine HCl 6.25 mgPhenylephrine HCl 2.5 mg

Purposes

Cough suppressantNasal decongestant

Antihistamine/cough suppressantNasal decongestant

Uses

  • •temporarily relieves onasal and sinus congestion ocough due to minor throat and bronchial irritation as may occur with a cold

  • •temporarily relievesosneezing oitchy nose or throatorunny noseoitchy, watery eyes due to hay feveronasal and sinus congestionocough due to minor throat and bronchial irritation as may occur with a cold

Do Not Use

  • •in a child under 4 years of age •in a child who is 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

  • •in a child under 4 years of age •in a child who is 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. •with any other product containing diphenhydramine, even one used on skin •for the purpose of making your child sleepy

Ask A Doctor Before Use If Your Child Has

  • •heart disease •high blood pressure •thyroid disease •diabetes •cough that occurs with too much phlegm (mucus) •chronic cough that lasts, or as occurs with asthma

When Using This Product

  • •do not exceed recommended dosage

  • •do not exceed recommended dosage •may cause marked drowsiness •sedatives and tranquilizers may increase drowsiness •excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • •nervousness, dizziness or sleeplessness occurs •symptoms do not improve within 7 days or occur with a fever •cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.

  • •nervousness, dizziness or sleeplessness occurs •symptoms do not improve within 7 days or occur with a fever •cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • •may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor. •use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device. AgeDosechildren under 4 years of agedo not usechildren 4 to under 6 years of age5 mLchildren 6 to under 12 years of age 10 mL

  • •may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor. •use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.AgeDosechildren under 4 years of agedo not usechildren 4 to under 6 years of agedo not use unless directed by a doctorchildren 6 to under 12 years of age10 mL

Other Information

  • •store at 20°-25°C (68°-77°F)

  • •each 5 mL contains: sodium 3 mg •store at 20°-25°C (68°-77°F)

Inactive Ingredients

Acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C red no. 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Ask A Doctor Before Use If The Child Has

  • •heart disease •high blood pressure •thyroid disease •diabetes •glaucoma •cough that occurs with too much phlegm (mucus) •chronic cough that lasts, or as occurs with asthma •a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If The Child Is

Taking sedatives or tranquilizers

* Please review the disclaimer below.