NDC 63868-228 Quality Choice Effervescent Cold Relief Plus

Aspirin, Chlorpheniramine Maleate, And Phenylephrine Bitartrate

NDC Product Code 63868-228

NDC Code: 63868-228

Proprietary Name: Quality Choice Effervescent Cold Relief Plus 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: Aspirin, Chlorpheniramine Maleate, And Phenylephrine Bitartrate 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):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
25 MM
Imprint(s):
CF
Score: 1
Flavor(s):
LEMON (C73396)

NDC Code Structure

  • 63868 - Chain Drug Marketing Association
    • 63868-228 - Quality Choice Effervescent Cold Relief Plus

NDC 63868-228-20

Package Description: 20 TABLET, EFFERVESCENT in 1 CARTON

NDC Product Information

Quality Choice Effervescent Cold Relief Plus with NDC 63868-228 is a a human over the counter drug product labeled by Chain Drug Marketing Association. The generic name of Quality Choice Effervescent Cold Relief Plus is aspirin, chlorpheniramine maleate, and phenylephrine bitartrate. The product's dosage form is tablet, effervescent and is administered via oral form.

Labeler Name: Chain Drug Marketing Association

Dosage Form: Tablet, Effervescent - A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.

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.

Quality Choice Effervescent Cold Relief Plus 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.

  • ASPIRIN 325 mg/1
  • CHLORPHENIRAMINE MALEATE 2 mg/1
  • PHENYLEPHRINE BITARTRATE 7.8 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.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ASPARTAME (UNII: Z0H242BBR1)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • DOCUSATE SODIUM (UNII: F05Q2T2JA0)
  • MANNITOL (UNII: 3OWL53L36A)
  • POVIDONE K30 (UNII: U725QWY32X)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)

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: Chain Drug Marketing Association
Labeler Code: 63868
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: 01-01-2014 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: 12-31-2019 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.

Quality Choice Effervescent Cold Relief Plus Product Label Images

Quality Choice Effervescent Cold Relief Plus 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

Drug Facts

Active ingredients (in each effervescent tablet)             PurposeAspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . . .Pain reliever/fever reducerChlorpheniramine maleate 2 mg . . . . . . . . . . . . . . . . . AntihistaminePhenylephrine Bitartrate 7.8 mg . . . . . . . . . . . . . . . . . Nasal decongestant*Nonsteroidal anti-inflammatory drug

Otc - Purpose

Usestemporarily relieves these symptoms of the common cold:■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache■ minor aches and pains ■ runny nose■ sinus congestion and pressure

Warnings

WarningsReye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. (See note below)


Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock


Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed


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.

Otc - Do Not Use

Do not use■ if you have ever had an allergic reaction to any other pain reliever/fever reducer■ if you are allergic to aspirin ■ 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■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic. ■ you are taking sedatives or tranquilizers You have ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are■ presently taking a prescription drug.■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis

Otc - When Using

When using this product ■ do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by doctor.■ do not use more than directed■ you may get drowsy■ avoid alcoholic drinks■ excitability may occur, especially in children■ alcohol, sedatives and tranquilizers may increase drowsiness■ be careful when driving a motor vehicle or operating machinery

Otc - Stop Use

Stop use and ask a doctor if ■ you experience any of the following signs of stomach bleeding■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better■ an allergic reaction occurs. Seek medical help right away.■ pain or nasal congestion gets worse or lasts more than 7 days■ fever gets worse or lasts more than 3 days■ new symptoms occur■ redness or swelling is present■ ringing in the ears or a loss of hearing occurs■ nervousness, dizziness or sleeplessness occurs

Otc - Pregnancy Or Breast Feeding

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


It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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.

Dosage & Administration

Directions■ do not use more than directed  ■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours■ do not take more than 8 tablets in 24 hours■ children under 12 years: ask a doctor

Inactive Ingredient

Inactive ingredients: acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodiumbenzoate, sodium bicarbonate

Indications & Usage

Fast Relief of: Nasal Congestion, Runny Nose, Sneezing, Headache, Sinus Pain & Pressure

* Please review the disclaimer below.

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