NDC 69842-545 Cvs Daytime Severe Cold And Flu Relief Softgels

Acetaminohpen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

NDC Product Code 69842-545

NDC Code: 69842-545

Proprietary Name: Cvs Daytime Severe Cold And Flu Relief Softgels 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: Acetaminohpen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl 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 - LIGHT ORANGE)
Shape: CAPSULE (C48336)
Size(s):
20 MM
Imprint(s):
341
Score: 1

NDC Code Structure

  • 69842 - Cvs Pharmacy
    • 69842-545 - Cvs Daytime Severe Cold And Flu Relief Softgels

NDC 69842-545-24

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

NDC Product Information

Cvs Daytime Severe Cold And Flu Relief Softgels with NDC 69842-545 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Cvs Daytime Severe Cold And Flu Relief Softgels is acetaminohpen, dextromethorphan hbr, guaifenesin, phenylephrine hcl. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Cvs Pharmacy

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.

Cvs Daytime Severe Cold And Flu Relief Softgels 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.

  • ACETAMINOPHEN 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • GUAIFENESIN 200 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 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.

  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SORBITOL (UNII: 506T60A25R)
  • 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: 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: 06-05-2019 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.

Cvs Daytime Severe Cold And Flu Relief Softgels Product Label Images

Cvs Daytime Severe Cold And Flu Relief Softgels 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 Softgel)

Acetaminophen 325 mg Dextromethoprhan HBr 10 mgGuaifenesin 200 mgPhenlyephrine HCl 5 mg

Purpose

Pain reliever/fever reducerCough suppressantExpectorantNasal 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.

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • More than 8 softgels in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:
  • Skin reddeningblistersrashIf 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.

Ask A Doctor Before Use If You Have

  • Liver disease
  • Diabetes
  • Heart disease
  • Thyroid disease
  • High blood pressure
  • Trouble urinating due to an enlarged prostate gland
  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysemacough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are

Taking the blood thinning drug warfarin.

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.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: Taking more than the recommended dose can cause liver damage. 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


■ do not exceed 8 softgels 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 read each label to ensure correct dosing

Other Information

  • ■ store at room temperature

Inactive Ingredients

FD&C Yellow # 6, gelatin, glycerin, polyethylene glycol,


povidone, propylene glycol, purified water, sorbitol


sorbitan solution, titanium dioxide

Otc - Questions

Questions or comments? 1-888-333-9792

* Please review the disclaimer below.

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