NDC 11822-1988 Multi-symptom Cold And Flu Relief Daytime Nighttime

Acetaminophen Dextromethorphan Hbr Phenylephrine Hcl And Acetominophen Dextromethorphan Hbr Doxylamine Succinate

NDC Product Code 11822-1988

NDC CODE: 11822-1988

Proprietary Name: Multi-symptom Cold And Flu Relief Daytime Nighttime 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 Phenylephrine Hcl And Acetominophen 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.

Product Characteristics

Color(s):
GREEN (C48329)
ORANGE (C48331)
Shape: OVAL (C48345)
Size(s):
21 MM
Imprint(s):
71
70
Score: 1

NDC Code Structure

NDC 11822-1988-0

Package Description: 2 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK

NDC 11822-1988-9

Package Description: 4 BLISTER PACK in 1 CARTON > 1 KIT in 1 BLISTER PACK

NDC Product Information

Multi-symptom Cold And Flu Relief Daytime Nighttime with NDC 11822-1988 is a a human over the counter drug product labeled by Rite Aid. The generic name of Multi-symptom Cold And Flu Relief Daytime Nighttime is acetaminophen dextromethorphan hbr phenylephrine hcl and acetominophen dextromethorphan hbr doxylamine succinate. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1086997, 1094549 and 1492380.

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.

  • SORBITAN (UNII: 6O92ICV9RU)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SHELLAC (UNII: 46N107B71O)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • GELATIN (UNII: 2G86QN327L)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SHELLAC (UNII: 46N107B71O)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)

Product Labeler Information

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

Labeler Name: Rite Aid
Labeler Code: 11822
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: 09-15-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

Multi-symptom Cold And Flu Relief Daytime Nighttime 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

Otc - Active Ingredient

Daytime cold &flu

Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg
nighttime cold &flu

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Otc - Purpose

Daytime cold & flu

Purpose

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant
nighttime cold & flu

Purpose

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

Indications & Usage

  • Uses
  • Temporarily relieves common cold/flu symptoms:
  • Nasal congestion
  • (Daytime only)cough due to minor throat & bronchial irritationsore throatheadacheminor aches & painsfeverrunny nose & sneezing
  • (Nithttime only)

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 amount for this productwtth other drugs containing acetaminophen3 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.

Otc - Do Not Use

  • Do not usewith 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 emotionalconditions, 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.

Otc - Ask Doctor

  • Ask a doctor before use if you haveliver diseaseglaucoma
  • (nighttime only)heart disease
  • (Daytime only)high blood pressure
  • (Daytime only)thyroid disease
  • (Daytime only)diabetes
  • (Daytime only)trouble urinating due to enlarged prostate glandcough that occurs with too much phlegm (mucus)persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • (Daytime only)a breathing problem or chronic cough that lasts or as occurs wtth smoking, asthma, chronic bronchitis or emphysema
  • (nighttime only)

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

  • When using this product, do not use more than directed.(daytime only)excitability may occur, especially in children
  • (nighttime only)marked drowsiness may occur
  • (nighttime only)avoid alcoholic drinks
  • (nighttime only)be carefull when driving a motor vehicle or operating machinery.
  • (nighttime only)alcohol, sedatives, & tranquilizers may increase drowsiness.
  • (nighttime only)

Otc - Stop Use

  • Stop use and ask a doctor ifyou get nervous, dizzy or sleepless
  • (daytime only)pain, nasal congestion or cough get worse or last more than 7 days
  • (daytime only)pain or cough gets worse or lasts more than 7 days
  • (nighttime only)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.

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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Dosage & Administration

  • Directionstake only as directeddo not exceed 4 doses per 24 hoursadults & children 12 yrs & over: 2 softgels with water every 4 hrs (daytime only)
  • Adults & children 12 yrs & over: 2 softgels with water every 6 hrs (nighttime only)
  • Children 4 to under 12 yrs:ask a doctor
  • Children under 4 yrs:do not use

Other Information

  • Other informationstore at room temperature

Inactive Ingredient

Daytime cold & fluInactive ingredients FD&C red#40, FD&C yellow#6, gelatin, glycerin, polyethylene glycol,

povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
nighttime cold & fluInactive ingredients FD&C blue#1, D&C yellow#10, gelatin, glycerin, polyethylene glycol,

povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Otc - Questions

Questions?call 1-877-290-4008

* Please review the disclaimer below.