NDC 55319-813 Daytime Nighttime Severe Cold And Flu

Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl Doxylaminesucinate

NDC Product Code 55319-813

NDC Code: 55319-813

Proprietary Name: Daytime Nighttime Severe Cold And Flu 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 Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl Doxylaminesucinate 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

  • 55319 - Family Dollar (family Wellness)
    • 55319-813 - Daytime Nighttime Severe Cold And Flu

NDC 55319-813-16

Package Description: 1 KIT in 1 KIT * 237 mL in 1 BOTTLE * 237 mL in 1 BOTTLE

NDC Product Information

Daytime Nighttime Severe Cold And Flu with NDC 55319-813 is a a human over the counter drug product labeled by Family Dollar (family Wellness). The generic name of Daytime Nighttime Severe Cold And Flu is acetaminophen dextromethorphan hbr guaifenesin phenylephrine hcl doxylaminesucinate. The product's dosage form is kit and is administered via form.

Labeler Name: Family Dollar (family Wellness)

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Product Labeler Information

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

Labeler Name: Family Dollar (family Wellness)
Labeler Code: 55319
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: 07-31-2019 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.

Daytime Nighttime Severe 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 15 Ml) Daytime

Acetaminophen 325 mgDextromethorphan HBr 10 mgGuaifenesin 200 mgPhenylephrine HCl 5 mg

Active Ingredients For (In Each 30 Ml) Nighttime

Acetaminophen 650 mgDextromethorphan HBr 20 mgDoxylamine Succinate 12.5 mgPhenylephrine HCL 10 mg

Purposes For Day Time

Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant

Purpose For Night Time

Pain reliever/fever reducerCough suppressantAntihistamineNasal decongestant

Uses

  • DAYTIMEtemporarily relieves common cold and flu symptoms
  • Nasal congestionsinus congestion and pressureminor aches and painheadachefeversore throatreduces swelling of nasal passagescough due to minor throat and bronchial irritationtemporarily restores freer breathing through the nose promotes nasal and/or sinus drainagehelp loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productiveNIGHTTIME  temporarily relieves these common cold/flu symptoms`
  • Nasal congestionsore throatheadachesinus congestion and pressureminor aches and painsrunny nose and sneezingcough due to minor throat and bronchial irritationtemporarily reducesfevercough to help you sleepswelling of nasal passage temporarily restores freer breathing through the nosepromotes nasal and/or sinus drainage

Warnings

  • DAYTIMELiver warning: This product contains acetaminophen. Severe liver damage may occur if:adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amountchild takes more than 4 doses (15 mL each) in 24 hourstaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrash.If 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.NIGHTTIMELiver warning: This product contains acetaminophen. Severe liver damage may occur if you take:more than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrash.if 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

  • DAYTIME NIGHTTIMEwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacistIf you are 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask A Doctor Before Use If You Have

  • DAYTIMEliver diseaseheart disease high blood pressurethyroid diseasediabetes a sodium-restricted diettrouble urinating due to an enlarged prostate glandpersistent or chronic cough such as occurs with smoking, asthma, or emphysemacough that occurs with too much phlegm (mucus)NIGHTTIMEliver diseaseheart disease high blood pressurethyroid diseasediabetesglaucomacough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysematrouble urinating due to enlarged prostate glanda sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

  • DAYTIME taking the blood thinning drug warfarin.NIGHTTIMEtaking sedatives or tranquilizerstaking the blood thinning drug warfarin

When Using This Product

  • DAYTIMEdo not take more than directed.NIGHTTIMEdo not take more than directedexcitability may occur, especially in childrenmarked drowsiness may occur avoid alcoholic drinksbe careful when driving a motor vehicle or operating machineryalcohol, sedatives and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • DAYTIMEnervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult)fever gets worse, or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back, or occurs with rash or headache that lasts.These could be signs of a serious condition.NIGHTTIMEnervousness, dizziness, or sleeplessness occurpain, nasal congestion, or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough 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.

DAYTIME NIGHTTIMETaking 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

  • DAYTIMEdo not take more than directed (see Overdose warning)do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL= milliliter adults and children 12 years and over30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 yearsask a doctor children under 4 years do not use NIGHTTIMEtake only as directed (see Overdose warning)Do not exceed 4 doses per 24 hoursmeasure only with dosing cup provided. Do not use any other dosing device.   mL= milliliterkeep dosing cup with productadults and children 12 years and over: 30 mL every 4 hourschildren under 12 years of age: do not usewhen using other Daytime or Nighttime products, carefully read each label or ensure correct dosing

Other Information

  • DAYTIMEeach 15 mL contains: sodium 12 mgstore between 20-25ºC (68-77º). Do not refrigerateNIGHTTIMEeach 30 mL contains: sodium 64 mgstore between 20-25ºC (68-77ºF). Do not refrigerate

Inactive Ingredients

Day Time citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride,sodium citrate, sorbitol, sucralose, xantham gumNight Time anhydrous citric acid, FD&C blue #1, Fd&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, trisodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Product Label

FAMILY WELLNESS DayTime Nigttime Severe Cold and Flu Relief

* Please review the disclaimer below.

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