NDC 69842-632 Severe Cold And Flu Daytime Non Drowsy Nighttime

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride / Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

NDC Product Code 69842-632

NDC CODE: 69842-632

Proprietary Name: Severe Cold And Flu Daytime Non Drowsy 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, Guaifenesin, Phenylephrine Hydrochloride / Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride 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

NDC 69842-632-24

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Product Information

Severe Cold And Flu Daytime Non Drowsy Nighttime with NDC 69842-632 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Severe Cold And Flu Daytime Non Drowsy Nighttime is acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride / acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride. 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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE K30 (UNII: U725QWY32X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE K30 (UNII: U725QWY32X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 02-11-2020 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 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.

Severe Cold And Flu Daytime Non Drowsy Nighttime Product Label Images

Severe Cold And Flu Daytime Non Drowsy 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

Drug Facts

Drug Facts

Otc - Purpose

Active ingredients (in each softgel)                                PurposesAcetaminophen 325 mg............................Pain reliever/fever reducer








Dextromethorphan HBr 10 mg.............................Cough suppressant








Guaifenesin 200 mg.........................................................Expectorant








Phenylephrine HCl 5 mg......................................Nasal decongestant

Active ingredients (in each softgel)                              PurposesAcetaminophen 325 mg............................Pain reliever/fever reducer








Dextromethorphan HBr 10 mg.............................Cough suppressant








Doxylamine succinate 6.25 mg.....................................Antihistamine








Phenylephrine HCl 5 mg......................................Nasal decongestant

Uses

■ temporarily relieves common cold/flu symptoms:








■ nasal congestion ■ sinus congestion & pressure








■ cough due to minor throat & bronchial irritation








■ minor aches & 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.

■ temporarily relieves common cold/flu symptoms:








■ nasal congestion ■ sinus congestion & pressure








■ cough due to minor throat & bronchial irritation








■ cough to help you sleep ■ minor aches & pains ■ headache








■ fever ■ sore throat ■ runny nose & sneezing








■ reduces swelling of nasal passages








■ temporarily restores freer breathing through the nose








■ promotes nasal and/or sinus drainage

Warnings

Liver warning This product contains acetaminophen. Severe liver








damage may occur if you take








■ more than 4 doses in 24 hours, which is the maximum daily








amount for this product








■ with other drugs containing acetaminophen








■ 3 or more alcoholic drinks every day while using this product

Allergy alert Acetaminophen may cause severe skin reactions.








Symptoms may include: ■ skin reddening ■ blisters ■ rash








If 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 doses in 24 hours, which is the maximum daily








amount for this product








■ with other drugs containing acetaminophen








■ 3 or more alcoholic drinks every day while using this product

Allergy alert Acetaminophen may cause severe skin reactions.








Symptoms may include: ■ skin reddening ■ blisters ■ rash








If 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.

Other

Drug Facts (continued)

Drug Facts (continued)

NIGHTTIME SEVERE COLD & FLU SOFTGELS

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.

■ 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.








■ to make a child sleep

Ask A Doctor Before Use If You Have

■ liver disease ■ heart disease ■ high blood pressure








■ thyroid disease ■ diabetes








■ trouble urinating due to 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

■ liver disease ■ heart disease ■ high blood pressure








■ thyroid disease ■ diabetes ■ glaucoma








■ cough that occurs with too much phlegm (mucus)








■ a breathing problem or chronic cough that lasts or as occurs with








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 the blood








thinning drug warfarin.

Otc - When Using

When using this product, 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.

Otc - Pregnancy Or Breast Feeding

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Keep out of reach of children.

Overdose Warning

Taking more than directed can cause serious








health problems. In case of overdose, get medical help or contact a








Poison Control Center right away. Quick medical attention is critical








for adults as well as for children even if you do not notice any signs








or symptoms.

Taking more than directed can cause serious








health problems. In case of overdose, get medical help or contact a








Poison Control Center right away. 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■ do not exceed 4 doses per 24 hours








 adults & children 12 years & over 2 softgels with water every








4 hours








 children 4 to under 12 years ask a doctor children under 4 years do not use■ when using other Nighttime or Daytime products, carefully readeach label to ensure correct dosing

■ take only as directed - see








Overdose warning■ do not exceed 4 doses per 24 hours








 adults & children 12 years & over 2 softgels with water every








4 hours








 children 4 to under 12 years ask a doctor children under 4 years do not use

Other Information

■ store at room temperature

Store at room temperature

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

D&C Yellow #10, FD&C Blue #1, gelatin,








glycerin, polyethylene glycol 400, povidone K30, propylene glycol,








purified water, shellac, sorbitol sorbitan, sodium hydroxide, titanium








dioxide

Nighttime Severe Cold & Flu Softgels

Drug Facts (continued)

Drug Facts (continued)

Ask A Doctor Or Pharmacist Before Use If You Are

■ taking sedatives or tranquilizers








■ 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

* Please review the disclaimer below.