Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief Kit
FDA Label NDC 68016-879

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Cold And Flu Multi-symptom Relief/cold And Flu Nighttime Relief (NDC 68016-879). 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 drug facts - day time, drug facts - night time, purpose - day time, purpose - night time, uses - day time, uses - night time, warnings - day time, warnings - night time, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts - Day Time

Active ingredients (in each capsule)

Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Phenylephrine HCl USP 5 mg

Drug Facts - Night Time

Active ingredients (in each capsule)

Acetaminophen USP 325 mg
Dextromethorphan HBr USP 15 mg
Doxylamine succinate USP 6.25 mg

Purpose - Day Time

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Purpose - Night Time

Pain reliever/fever reducer
Cough suppressant
Antihistamine



Uses - Day Time

temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever

Uses - Night Time

temporarily relieves common cold/flu symptoms:

    • nasal congestion
    • cough due to minor throat & bronchial irritation
    • sore throat
    • headache
    • minor aches & pains
    • fever

    • runny nose & sneezing

Warnings - Day Time

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

    • Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Warnings - Night Time

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

    • Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Do Not Use - Day Time

  • 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.

Do Not Use - Night Time

  • 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 - Day Time


  • liver disease

  • heart disease

  • thyroid disease

  • diabetes

  • high blood pressure

  • trouble urinating due to enlarged prostate gland

  • cough that occurs with too much phlegm (mucus)

  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask A Doctor Before Use If You Have - Night Time

  • liver disease
  • 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

Ask A Doctor Or Pharmacist Before Use If You Are - Day Time

taking the blood thinning drug warfarin

Ask A Doctor Or Pharmacist Before Use If You Are - Night Time

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

When Using This Product,

do not use more than directed.

When Using This Product - Night Time

  • 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, & tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If - Day Time

  • you get nervous, dizzy or sleepless

  • symptoms get worse or last more than 5 days (children) or 7 days (adults)

  • 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.

Stop Use And Ask A Doctor If - Night Time

  • pain 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.

If Pregnant Or Breast-Feeding, - Night Time

ask a health professional before use.

Keep Out Of Reach Of Children. - Day Time

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 (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Keep Out Of Reach Of Children. - Night Time

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 (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions - Day Time

  • take only as directed – see Overdose warning
  • do not exceed 4 doses per 24 hours

    • adults & children 12 yrs & over
    		2 capsules with water every 4 hrs
    children 4 to under 12 yrs
    		ask a doctor
    children under 4 yrs
    		do not use

    when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Directions - Night Time

  • take only as directed – see Overdose warning
  • do not exceed 4 doses per 24 hours

    • adults & children 12 yrs & over
    		2 capsules with water every 6 hrs
    children 4 to under 12 yrs
    		ask a doctor
    children under 4 yrs
    		do not use

    when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other Information - Day Time

  • store at room temperature

Other Information - Night Time

  • store at room temperature

Inactive Ingredients - Day Time

citric acid anhydrous, gelatin, glycerin, Neelicert FD & C Red No. 40, Neelicert FD & C Yellow No. 6, noncrystallizing sorbitol solution, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, titanium dioxide

Inactive Ingredients - Night Time

D&C Yellow No. 10, gelatin, glycerin, Neelicert FD&C Blue No. 1, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

call 1-855-274-4122
 
Distributed by:
Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, Pa 19087


Package Label-Principal Display Panel 16 Fl Oz (474 Ml Bottle)

NDC 68016-879-18

Premier Value®


COMPARE TO THE ACTIVE INGREDIENTS IN
VICKS® DAYQUIL® AND VICKS® Nyquil® COLD &
FLU MULTI-SYMPTOM RELIEF LIQUICAPS®

Non-Drowsy                                                  Multi-Symptom
Daytime                                                          Nighttime

                                    COLD & FLU RELIEF

Acetaminophen,                                              Acetaminophen,
Dextromethorphan HBr and                         Dextromethorphan HBr,
Phenylephrine HCl Capsules                         Doxylamine Succinate Capsules
325 mg/10 mg/5 mg                                         325 mg/15 mg/6.25 mg

     •  Aches, Fever & Sore Throat                  •  Aches, Fever & Sore Throat
     •   Nasal Congestion                                  •  Sneezing, Runny Nose
     •   Cough                                                   •  Cough

                                       32 Capsules               16 Capsules

Package Label-principal Display Panel (48 Capsule Bottle)

Package Label-principal Display Panel (48 Capsule Bottle)

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