NDC 68016-881 Nighttime Cold/flu Relief Softgels

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate

NDC Product Code 68016-881

NDC CODE: 68016-881

Proprietary Name: Nighttime Cold/flu Relief Softgels 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, Doxylamine Succinate 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

NDC 68016-881-16

Package Description: 2 BLISTER PACK in 1 CARTON > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC 68016-881-24

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

NDC Product Information

Nighttime Cold/flu Relief Softgels with NDC 68016-881 is a a human over the counter drug product labeled by Pharmacy Value Alliance, Llc. The generic name of Nighttime Cold/flu Relief Softgels is acetaminophen, dextromethorphan hbr, doxylamine succinate. The product's dosage form is capsule, liquid filled and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1094549.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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/flu Relief Softgels 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.

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

Product Labeler Information

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

Labeler Name: Pharmacy Value Alliance, Llc
Labeler Code: 68016
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: 02-28-2020 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 - 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".

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Nighttime Cold/flu Relief Softgels Product Label Images

Nighttime Cold/flu Relief Softgels 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 - Active Ingredient

Active ingredients (in each softgel)Acetaminophen                325 mgDextromethorphan HBr      15 mg Doxylamine Succinate     6.25 mg

Otc - Purpose

PurposeAcetaminophen …………….….Pain reliever/fever reducerDextromethorphan HBr .....Cough suppressantDoxylamine succinate ……...Antihistamine

Indications & Usage

Uses temporarily relieves common cold/flu symptoms:• cough due to minor throat and bronchial irritation• sore throat • headache • minor aches & pains • fever• runny nose and sneezing

Warnings

Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take:• more than 4 doses, in 24 hrs, which is the maximum daily amountfor this product with other drugs containing acetaminophen • 3or more alcoholic drinks daily while using this productAllergy Alert: Acetaminophen may cause severe skinreactions. 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, lasts for more than 2days, occurs with or is followed by fever, headache, rash,nausea, or vomiting, consult a doctor promptly.

Otc - Do Not Use

Do not use • with any other drug containing acetaminophen(prescription or nonprescription). If you are not sure whether a drugcontains acetaminophen, ask a doctor or pharmacist• if you are now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotionalconditions, or Parkinson's disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your prescription drug contains anMAOI, ask a doctor or pharmacist before taking this product.• to make a child sleepy

Otc - Ask Doctor

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 lasts or as occurswith smoking, asthma, chronic bronchitis or emphysema• trouble urinating due to enlarged prostate gland.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are• taking sedatives or tranquilizers• taking the blood thinning drug warfarin

Otc - When Using

When using this product do not use more than directed.• 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 & tranquilizers may increase drowsiness

Otc - Stop Use

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 lasts.These 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.In case of accidental overdose, get medical help or contacta Poison Control Center right away. Quick medical attention iscritical for adults as well as children, even if you do not noticeany signs or symptoms.

Dosage & Administration

Directions• take only as directed (see Warnings)• do not exceed 4 doses per 24 hrs adults & children 12 years & over 2 softgel with water every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use• when using other Daytime or Nighttime products,  carefully read each label to ensure correct dosing

Other Safety Information

Other information• Store at room temperature 20-25oC (68-77oF)• avoid excessive heat

Inactive Ingredient

Inactive ingredients D&C yellow # 10, FD&C Blue # 1,Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide

Otc - Questions

Questions? Call weekdays from 9:30 am to 4:30 pm EST.1-877-798-5944

Product Label

PremierValue®*COMPARE TO THE ACTIVE INGREDIENTSIN VICKS® NYQUIL® COLD & FLUNIGHTTIME RELIEF LIQUICAPS®NighttimeCOLD/FLU RELIEFAcetaminophen/ Dextromethorphan HBr/Doxylamine Succinate• Aches, Fever & Sore Throat• Sneezing, Runny Nose• Cough16 Softgels   INDEPENDENTLY TESTED                PVSATISFACTION GUARANTEEDDistributed by:Pharmacy Value Alliance, LLC407 East Lancaster Avenue,Wayne, PA 19087   INDEPENDENTLY TESTED                 PVSATISFACTION GUARANTEEDIf for any reason you are not completely satisfied withthis product, please return it to the storewhere purchased for a full refund.Failure to follow these warningscould result in serious consequences.TAMPER EVIDENT: DO NOT USE IFCARTON IS OPEN OR BLISTERUNIT IS TORN, BROKEN OR SHOWSANY SIGNS OF TAMPERING.KEEP OUTER BOX FOR COMPLETEWARNINGS AND PRODUCTINFORMATION.BX-096   5098188 1/2016 Softgels Label24 SofTgels Labelres

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