NDC 69842-737 Cooling Severe Daytime Cooling Severe Nighttime

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride,guaifenesin

NDC Product Code 69842-737

NDC Code: 69842-737

Proprietary Name: Cooling Severe Daytime Cooling Severe 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 Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride,guaifenesin 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

  • 69842 - Cvs Pharmacy
    • 69842-737 - Cooling Severe Daytime Cooling Severe Nighttime

NDC 69842-737-02

Package Description: 1 KIT in 1 PACKAGE * 355 mL in 1 BOTTLE (69842-590-40) * 355 mL in 1 BOTTLE (69842-182-40)

NDC Product Information

Cooling Severe Daytime Cooling Severe Nighttime with NDC 69842-737 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Cooling Severe Daytime Cooling Severe Nighttime is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride,guaifenesin. The product's dosage form is kit and is administered via form.

Labeler Name: Cvs Pharmacy

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • ALCOHOL (UNII: 3K9958V90M)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Labeler Information

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

Labeler Name: Cvs Pharmacy
Labeler Code: 69842
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: 07-23-2019 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: 12-31-2020 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.

Cooling Severe Daytime Cooling Severe Nighttime Product Label Images

Cooling Severe Daytime Cooling Severe 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

Active Ingredients (In Each 30 Ml) – Night Time

Acetaminophen 650 mgDextromethorphan HBr 20 mgDoxylamine succinate 12.5 mgPhenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducerCough suppressantAntihistamineNasal decongestant

Pain reliever/fever reducer Cough suppressantExpectorantNasal decongestant

Uses

  • Temporarily relieves common cold/flu symptoms: •nasal congestion •sinus congestion and pressure •minor aches and pains •headache •fever •sore throat •runny nose and sneezing •cough due to minor throat and bronchial irritation •cough to help you sleep •reduces swelling of nasal passages •promotes nasal and/or sinus drainage •temporarily restores freer breathing through the nose

  • Temporarily relieves common cold/flu symptoms: •nasal congestion •sinus congestion and pressure •cough due to minor throat and bronchial irritation •minor aches and pains •headache •fever •sore throat •reduces swelling of nasal passages •temporarily restores freer breathing through the nose •promotes nasal and/or sinus drainage •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take •more than 4,000 mg of acetaminophen in 24 hours •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take •more than 4,000 mg of acetaminophen in 24 hours •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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. •if you have ever had an allergic reaction to this product or any of its ingredients

  • •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. •if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

  • •liver disease •heart disease •high blood pressure •thyroid disease •diabetes •glaucoma •cough that occurs with too much phlegm (mucus) •a breathing problem such as emphysema or chronic bronchitis •trouble urinating due to an enlarged prostate gland •persistent or chronic cough such as occurs with smoking, asthma, or emphysema •a sodium-restricted diet

  • •liver disease •heart disease •thyroid disease •diabetes •high blood pressure •trouble urinating due to an enlarged prostate gland •cough that occurs with too much phlegm (mucus) •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema •a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

  • •taking sedatives or tranquilizers •taking the blood thinning drug warfarin

Taking the blood thinning drug warfarin

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, and tranquilizers may increase drowsiness

Do not use more than directed

Stop Use And Ask A Doctor If

  • •you get nervous, dizzy or sleepless •pain, nasal congestion, 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.

  • •you get nervous, dizzy or sleepless •pain, nasal congestion, 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.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 warning •only use the dose cup provided •do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use

  • •take only as directed – see Overdose warning •only use the dose cup provided •do not exceed 4 doses per 24 hrsadults & children 12 yrs & over30 mL every 4 hrschildren 4 to under 12 yrsask a doctorchildren under 4 yrsdo not use

Other Information

  • •each 30 mL contains: sodium 42 mg •store at 20-25°C (68-77°F)

  • •each 30 mL contains: sodium 41 mg •store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

Alcohol, anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

Alcohol, anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose

Active Ingredients (In Each 30 Ml) - Day Time

Acetaminophen 650 mgDextromethorphan HBr 20 mgGuaifenesin 400 mgPhenylephrine HCl 10 mg

* Please review the disclaimer below.

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