NDC 15127-346 Cold And Flu Nighttime

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate

NDC Product Code 15127-346

NDC 15127-346-06

Package Description: 177 mL in 1 BOTTLE, PLASTIC

NDC 15127-346-10

Package Description: 296 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Cold And Flu Nighttime with NDC 15127-346 is a a human over the counter drug product labeled by Select Brand Dist.. The generic name of Cold And Flu Nighttime is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate. The product's dosage form is liquid and is administered via oral form.

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.

Cold And Flu Nighttime 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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ALCOHOL (UNII: 3K9958V90M)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

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: Select Brand Dist.
Labeler Code: 15127
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: 03-31-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-30-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Cold And Flu Nighttime 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 15 Ml)

Acetaminophen 500 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.5 mg

Purposes

Pain reliever/fever reducerCough suppressantAntihistamine

Uses

  • Temporarily relieves these common cold/flu symptoms: minor aches and painsheadachesore throatfeverrunny nose and sneezingitchy nose or throatcoughscough due to minor throat and bronchial irritation

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses (120 mL) in 24 hours, which is the maximum daily amount
  • With other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this productSore 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 make a child sleepy
  • 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 drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacistif you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If You Have

  • Liver disease
  • Glaucoma
  • Breathing problemschronic bronchitisa sodium-restricted diettrouble urinating due to an enlarged prostate glandpersistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are Taking

  • Sedatives or tranquilizers
  • The blood thinning drug warfarin

When Using This Product

  • Do not use more than directed (see overdose warning)excitability may occur, especially in children
  • Marked drowsiness may occur
  • Avoid alcoholic drinks
  • Be careful when driving a motor vehicle or operating machinery
  • Alcohol, sedatives and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • Redness or swelling is presentnew symptoms occurfever 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.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • Take only as recommended (see overdose warningdo not exceed 4 doses in any 24-houruse dosage cup providedmL= milliliter agedoseadults & children 12 years and over30 mL every 6 hrschildren 4 to 11 yrsdo not use unless directed by a doctorchildren under 4 yrsdo not useWhen using other Day Time or Night Time products, carefully read each label to ensure correct dosing

Other Information

  • Each 15 mL contains: sodium 18 mgstore at room temperature.

Inactive Ingredients

Alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6,, flavor,high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Product Label

Select Brand NightTime Cold & Flu Original Liquid

* Please review the disclaimer below.