NDC 73147-3111 Nighttime Cold And Cough Sugar-free

Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

NDC Product Code 73147-3111

NDC CODE: 73147-3111

Proprietary Name: Nighttime Cold And Cough Sugar-free 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, 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.

NDC Code Structure

  • 73147 - Cellchem Pharmaceuticals Inc
    • 73147-3111 - Nighttime Cold And Cough Sugar-free

NDC 73147-3111-6

Package Description: 6 POWDER in 1 BOX, UNIT-DOSE

NDC Product Information

Nighttime Cold And Cough Sugar-free with NDC 73147-3111 is a a human over the counter drug product labeled by Cellchem Pharmaceuticals Inc. The generic name of Nighttime Cold And Cough Sugar-free is acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride. The product's dosage form is powder and is administered via oral form.

Labeler Name: Cellchem Pharmaceuticals Inc

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Nighttime Cold And Cough Sugar-free 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/1
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/1

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)
  • ASPARTAME (UNII: Z0H242BBR1)
  • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

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: Cellchem Pharmaceuticals Inc
Labeler Code: 73147
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: 07-01-2019 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.

Nighttime Cold And Cough Sugar-free Product Label Images

Nighttime Cold And Cough Sugar-free 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

Drug Facts

Active Ingredients (in each packet)                                                    PurposeAcetaminophen 650 mg.........................................Pain reliever/Fever reducerDiphenhydramine Hydrochloride 25 mg.............Antihistamine/Cough SuppressantPhenylephrine Hydrochloride 10 mg......................................Nasal decongestant

Uses

  • Temporarily relieves these symptoms due to cold:minor aches and pains headacheminor sore throat painnasal and sinus congestioncough due to minor throat and bronchial irritationrunny nosesneezingitchy, watery eyes due to hay feveritchy nose or throatTemporarily reduces fever

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:more than 6 packets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product.Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may includeskin reddeningblistersrashIf 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

  • In a child under 12 years of ageif you are allergic to acetaminophenwith any other drug containing acetaminophen (prescription and non-prescription). 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 the skin 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 a MAOI, ask  a doctor or pharmacist before taking this product.

When Using This Product

  • Do not exceed recommended dosageavoid alcoholic drinksmarked drowsiness may occur alcohol, 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 occurs fever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurpain, cough or nasal congestion gets worse or lasts more than 7 dayscough comes back or occurs with rash or headache that lasts. 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. 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 use more than directedtake every 4 hours, while symptoms persist.Do not take more than 6 packets in 24 hours unless directed by a doctor.AgeDoseadults and children 12 years and overone packetchildren under 12 yearsdo not usedissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Information For Patients

  • Other Informationeach packet contains: potassium 10 mg, sodium 23 mg.phenylketonurics: contains phenylalanine 10 mg per packet.store at controlled room temperature 20-25°C (68 -77°F). Protect from heat and moisture.

Inactive Ingredients

Acesulfame potassium, aspartame, calcium phosphate dibasic, citric acid, D&C Yellow #10, maltodextrin, flavors, silicon dioxide, sodium citrate dihydrate.

* Please review the disclaimer below.