Multi Symptom Severe Cold And Nighttime Severe Cold And Cough Kit
FDA Label NDC 59779-768

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy,inc. for the product Multi Symptom Severe Cold And Nighttime Severe Cold And Cough (NDC 59779-768). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each packet) – multi symptom severe cold, active ingredients (in each packet) - nighttime severe cold and cough, purpose - multi symptom severe cold, purpose - nighttime severe cold and cough, uses - multi symptom severe cold, uses - nighttime severe cold and cough, warnings – multi symptom severe cold /nighttime severe cold and cough, do not use - multi symptom severe cold, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Packet) – Multi Symptom Severe Cold

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Active Ingredients (In Each Packet) - Nighttime Severe Cold And Cough

Acetaminophen 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purpose - Multi Symptom Severe Cold

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Purpose - Nighttime Severe Cold And Cough

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses - Multi Symptom Severe Cold

  • temporarily relieves these symptoms due to a cold:
  • minor aches and pains
  • minor sore throat pain
  • headache
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Uses - Nighttime Severe Cold And Cough

  • temporarily relieves these symptoms due to a cold:
  • minor aches and pains
  • minor sore throat pain
  • headache
  • nasal and sinus congestion
  • runny nose
  • sneezing
  • itchy nose or throat
  • itchy, watery eyes due to hay fever
  • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

Warnings – Multi Symptom Severe Cold /Nighttime Severe Cold And Cough

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 product

    • 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 - Multi Symptom Severe Cold

  • in a child under 4 years of age
  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.

Do Not Use - Nighttime Severe Cold And Cough

  • in a child under 4 years of age
  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
  • with any other product containing diphenhydramine, even one used on skin
  • 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 - Multi Symptom Severe Cold

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask A Doctor Before Use If You Have - Nighttime Severe Cold And Cough

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

Ask A Doctor Or Pharmacist Before Use If You Are - Multi Symptom Severe Cold

taking the blood thinning drug warfarin

Ask A Doctor Or Pharmacist Before Use If You Are - Nighttime Severe Cold And Cough

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

When Using This Product - Multi Symptom Severe Cold

do not exceed recommended dosage

When Using This Product - Nighttime Severe Cold And Cough

  • do not exceed recommended dosage
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop Use And Ask A Doctor If – Multi Symptom Severe Cold /Nighttime Severe Cold And Cough

  • nervousness, dizziness, or sleeplessness occurs
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • symptoms do not get better or worsen
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • cough comes back or occurs with fever, 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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions – Multi Symptom Severe Cold

  • do not use more than directed
  • take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor
    • AgeDosechildren under 4 years of agedo not usechildren 4 to under 12 years of agedo not use unless directed by a doctoradults and children 12 years of age and overone packet
     
     
     
     
     
     
     
     

Directions Nighttime Severe Cold And Cough

  • do not use more than directed
  • take every 4 hours; not to exceed 5 packets in 24 hours or as directed by a doctor
    • AgeDosechildren under 4 years of agedo not usechildren 4 to under 12 years of agedo not use unless directed by a doctoradults and children 12 years of age and overone packet
     
     
     
     
     
     
     
     

Other Information - Multi Symptom Severe Cold

  • each packet contains: potassium 6 mg
  • store at controlled room temperature 20°-25oC (68°-77oF). Protect from excessive heat and moisture.

Other Information - Nighttime Severe Cold And Cough

  • each packet contains: potassium 6 mg
  • store at controlled room temperature 20°-25oC (68°-77oF). Protect from excessive heat and moisture

Inactive Ingredients - Multi Symptom Severe Cold

anhydrous citric acid, caramel, flavors, maltodextrin, potassium citrate, silica ,sucralose, sucrose

Inactive Ingredients - Nighttime Severe Cold And Cough

anhydrous citric acid, flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose, yellow #6

Questions Or Comments?

1-866-467-2748

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Multi Symptom Severe Cold 6 PACKETS + NIGHTTIME 6 PACKETS = 12 PACKETS TOTAL

Compare to the active ingredients in Theraflu® Multi Symptom Severe Cold and Nighttime Severe Cold & Cough

Multi Symptom

Severe Cough & Cold

ACETAMINOPHEN - Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr – Cough suppressant

PHENYLEPHRINE HCl – Nasal decongestant

Relieves:

Nasal congestion

Sore throat pain

Cough

Headache

Body ache

Fever

Green Tea & Honey Lemon Flavors

6 PACKETS

NIGHTTIME

Severe Cough & Cold

ACETAMINOPHEN - Pain reliever; Fever reducer

DIPHENHYDRAMINE HCl – Antihistamine; Cough suppressant

PHENYLEPHRINE HCl – Nasal decongestant

Relieves:

Nasal congestion

Sore throat pain

Cough

Headache

Body ache

Fever

Runny nose

Sneezing

Honey Lemon Flavor Infused with Chamomile &White Tea Flavors

6 PACKETS

Cvs Health Multi Symptom Severe Cold And Nighttime Severe Cold And Cough (49516a11 E910 4ce0 Be95 F9f6e78b9df5 01)

Cvs Health Multi Symptom Severe Cold And Nighttime Severe Cold And Cough (49516a11 E910 4ce0 Be95 F9f6e78b9df5 01)

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