NDC 49738-480 Nighttime Cold And Flu

NDC Product Code 49738-480

NDC 49738-480-24

Package Description: 2 BLISTER PACK in 1 CARTON > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

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

NDC Product Information

Nighttime Cold And Flu with NDC 49738-480 is a product labeled by Smart Sense (kmart). The generic name of Nighttime Cold And Flu is . The product's dosage form is and is administered via form.

Labeler Name: Smart Sense (kmart)

Dosage Form: -

Product Type: 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.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONES (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SORBITOL (UNII: 506T60A25R)

Product Labeler Information

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

Labeler Name: Smart Sense (kmart)
Labeler Code: 49738
Start Marketing Date: 12-31-2012 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: 12-31-2018 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 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.

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]
Doxylamine

Doxylamine is pronounced as (dox il' a meen)
Why is doxylamine medication prescribed?
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and ot...
[Read More]

* 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 Softgel)

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Purposes

Pain reliever/fever reducerCough suppressantAntihistamine

Uses

  • Temporarily relieves common cold and flu symptoms: sore throat
  • Headache
  • Minor aches and pains
  • 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 mg of acetaminophen in 24 hours
  • 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 sleep
  • 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.

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers

When Using This Product

  • Do not exceed recommended dosageexcitability may occur, especially in children
  • Avoid alcoholic drinks
  • Marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • Pain or cough gets worse or lasts more than 7 days
  • Fever gets worse or lasts more than 3 days
  • Redness or swelling is present
  • New symptoms occur
  • Cough comes back or occurs with 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.

Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 24 hours
  • Adults and children 12 years and over: take 2 softgels with water every 6 hours
  • Swallow whole; do not crush, chew, or dissolve
  • Children under 12 years: do not use
  • When using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other Information

  • Store at room temperature 15°-30°C (59°-86°F)
  • Avoid excessive heat

Inactive Ingredients

D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Product Label

Smart Sense Nighttime Cold and Flu Softgel

* Please review the disclaimer below.