NDC 49035-669 Severe Nighttime Cold And Flu

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride

NDC Product Code 49035-669

NDC CODE: 49035-669

Proprietary Name: Severe Nighttime 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 Hydrobromide, Doxylamine Succinate, And 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Product Characteristics

Color(s):
GREEN (C48329)
Shape: OVAL (C48345)
Size(s):
20 MM
Imprint(s):
116
Score: 1

NDC Code Structure

  • 49035 - Wal-mart Stores Inc

NDC 49035-669-24

Package Description: 2 BLISTER PACK in 1 CARTON > 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK

NDC Product Information

Severe Nighttime Cold And Flu with NDC 49035-669 is a a human over the counter drug product labeled by Wal-mart Stores Inc. The generic name of Severe Nighttime Cold And Flu is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride. The product's dosage form is capsule, gelatin coated and is administered via oral form.

Labeler Name: Wal-mart Stores Inc

Dosage Form: Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.

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.

Severe 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 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • DOXYLAMINE SUCCINATE 6.25 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 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.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE K30 (UNII: U725QWY32X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.
  • 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: Wal-mart Stores Inc
Labeler Code: 49035
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: 01-14-2020 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: 12-31-2021 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.

Severe Nighttime Cold And Flu Product Label Images

Severe 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

Other

Drug Facts

Otc - Purpose

Active ingredients (in each softgel)PurposesAcetaminophen 325 mgPain reliever/fever reducerDextromethorphan HBr 10 mgCough suppressantDoxylamine succinate 6.25 mgAntihistaminePhenylephrine HCl 5 mgNasal decongestant

Uses

  • Temporarily relieves common cold/flu symptoms:nasal congestionsinus congestion & pressurecough due to minor throat & bronchial irritationcough to help you sleepminor aches & painsheadachefeversore throatrunny nose & sneezingreduces swelling of nasal passagestemporarily restores freer breathing through the nosepromotes nasal and/or sinus drainage

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if you takemore than 4 doses in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

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.

Allergy Alert

  • Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

  • 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.to make a child sleep

Ask A Doctor Before Use If You Have

  • Liver diseaseheart diseasehigh 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 gland

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking sedatives or tranquilizerstaking the blood thinning drug warfarin

When Using This Product

  • Do not use more than directedexcitability may occur, especially in childrenmarked drowsiness may occuravoid alcoholic drinksbe careful when driving a motor vehicle or operating machineryalcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • You get nervous, dizzy or sleeplesspain, 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 lastsThese could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center 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

  • Take only as directed - see
  • Overdose warningdo not exceed 4 doses per 24 hoursadults & children 12 years & over2 softgels with water every 4 hourschildren 4 to under 12 yearsask a doctorchildren under 4 yearsdo not use

Other Information

  • Store at room temperature

Inactive Ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, shellac, sorbitol sorbitan, sodium hydroxide, titanium dioxide

Princupal Display Panel

Compare to Vicks® NyQuil® Severe Cold & Flu active ingredientsNIGHTTIME Severe Cold & FluACETAMINOPHEN/ PAIN RELIEVER/ FEVER REDUCERDEXTROMETHORPHAN HBR/ COUGH SUPPRESSANTDOXYLAMINE SUCCINATE/ ANTIHISTAMINEPHENYLEPHRINE HCL/ NASAL DECONGESTANTMAXIMUM STRENGTHRelieves headache, fever, sore throat, minor aches & pains, nasal/sinus congestion & sinus





pressure, sneezing, runny nose & cough





24 SOFTGELS

* Please review the disclaimer below.