NDC 11822-1989 Multi-symptom Cold And Flu Relief Daytime

Acetaminophen 325 Mg Dextromethorphan Hbr 10 Mg Phenylephrine Hci 5 Mg

NDC Product Code 11822-1989

NDC CODE: 11822-1989

Proprietary Name: Multi-symptom Cold And Flu Relief Daytime 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 325 Mg Dextromethorphan Hbr 10 Mg Phenylephrine Hci 5 Mg 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):
ORANGE (C48331)
Shape: OVAL (C48345)
Size(s):
21 MM
Imprint(s):
70
Score: 1

NDC Code Structure

NDC 11822-1989-0

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

NDC 11822-1989-9

Package Description: 4 BLISTER PACK in 1 CARTON > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Multi-symptom Cold And Flu Relief Daytime with NDC 11822-1989 is a a human over the counter drug product labeled by Rite Aid. The generic name of Multi-symptom Cold And Flu Relief Daytime is acetaminophen 325 mg dextromethorphan hbr 10 mg phenylephrine hci 5 mg. 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: 1086997.

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.

Multi-symptom Cold And Flu Relief Daytime 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.

  • SORBITOL (UNII: 506T60A25R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • WATER (UNII: 059QF0KO0R)
  • 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: 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 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

Active ingredients (in each softgel)
Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Otc - Purpose

PurposePain reliever/Fever reducer
Cough suppressant

Nasal decongestant

Indications & Usage

  • Uses
  • Temporarily relieves common cold/flu symptoms:
  • Nasal congestioncough due to minor throat & bronchial irritationsore throatheadacheminor aches & painsfever

Warnings

  • WarningsLiver 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 productwith 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 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.

Otc - Ask Doctor

  • Ask a doctor before use if you haveliver diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble 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

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product, do not use more than directed.

Otc - Stop Use

  • Stop use and ask a doctor ifyou get nervous, dizzy or sleeplesspain, nasal congestion or cough get worse or last 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.

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
  • 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

Inactive ingredients FD&C red#40, FD&C yellow#6, 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.