NDC 46994-344 Nighttime Cold And Flu

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate

NDC Product Code 46994-344

NDC 46994-344-08

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Nighttime Cold And Flu with NDC 46994-344 is a a human over the counter drug product labeled by Being Well. The generic name of Nighttime Cold And Flu is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Being Well

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.

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/30mL
  • DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL
  • DOXYLAMINE SUCCINATE 12.5 mg/30mL

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 GLYCOL, UNSPECIFIED (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: Being Well
Labeler Code: 46994
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: 08-30-2019 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: 12-31-2020 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.

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 30 Ml)

Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg

Purposes

Pain reliever/fever reducerCough suppressantAntihistamine

Uses

  • Temporarily relieves common cold/flu symptoms:
  • Minor aches and pains
  • Headache
  • Sore throat
  • Fever
  • Runny nose and sneezing
  • Cough due to minor throat and bronchial irritation

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 doses of acetaminophen in 24 hours
  • With other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening
  • Blisters
  • RashIf 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

  • 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 pharmacist

Ask A Doctor Before Use If You Have

  • Liver disease
  • Glaucoma
  • Cough that occurs with too much phlegm (mucus)
  • A breathing problem or chronic cough that that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are Taking

  • Sedatives or tranquilizers
  • The blood thinning drug warfarin

When Using This Product

  • 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

  • Pain or cough gets worse or lasts more than 7 days
  • New symptoms occur
  • Fever gets worse or lasts more than 7 days
  • Redness or swelling is present
  • Cough 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) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • Do not take more than directed (see Overdose warning)do not take more than 4 doses in any 24-hours period
  • Measure only with dosing cup provided. Do not use any other dosing device.
  • ML= milliliter
  • Keep dosing cup with product
  • Adults and children 12 years and over: 30 mL every 6 hours
  • Children under 12 years of age: do not use
  • When using other Day Time or Night Time products, carefully read each label to ensure correct dosing

Other Information

  • Each 30 mL contains: potassium 5 mgeach 30 mL contains: Sodium 19 mgstore between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive Ingredients

Acesulfame potassium, 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

BEING WELL Nighttime Cold & Flu Relief

* Please review the disclaimer below.