SPL v3
SPL
SPL Set ID f9c3c12b-4efa-4ec4-a156-c403aff81753
Route
ORAL
Published
Effective Date 2024-10-24
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (15 mg)
Inactive Ingredients
Anhydrous Citric Acid Gelatin, Unspecified Glycerin Fd&c Red No. 40 Fd&c Yellow No. 6 Sorbitol Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Shellac Titanium Dioxide D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: Q07 Shape: oval Color: orange Color: green Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-12

Description

Active ingredients (in each capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Description

Active ingredients (in each capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg

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

Purpose Day Time

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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.

Purpose Night Time

Pain reliever/fever reducer

Cough suppressant

Antihistamine





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

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.
Drug Facts Day Time

Active ingredients (in each capsule)



Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Phenylephrine HCl USP 5 mg

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.

Questions Or Comments?

call 1-855-274-4122

 

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, Pa 19087



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

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
Drug Facts Night Time

Active ingredients (in each capsule)



Acetaminophen USP 325 mg

Dextromethorphan HBr USP 15 mg

Doxylamine succinate USP 6.25 mg

When Using This Product,

do not use more than directed.

Other Information Day Time
  • store at room temperature
If Pregnant Or Breast Feeding,

ask a health professional before use.

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

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.

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.

If Pregnant Or Breast Feeding, Night Time

ask a health professional before use.

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.

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
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




Structured Label Content

Uses Day Time (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 (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

Purpose Day Time (Purpose - Day Time)

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings Day Time (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.

Purpose Night Time (Purpose - Night Time)

Pain reliever/fever reducer

Cough suppressant

Antihistamine





Directions Day Time (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

Do Not Use Day Time (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.
Drug Facts Day Time (Drug Facts - Day Time)

Active ingredients (in each capsule)



Acetaminophen USP 325 mg

Dextromethorphan HBr USP 10 mg

Phenylephrine HCl USP 5 mg

Warnings Night Time (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.

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122

 

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, Pa 19087



Directions Night Time (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

Do Not Use Night Time (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
Drug Facts Night Time (Drug Facts - Night Time)

Active ingredients (in each capsule)



Acetaminophen USP 325 mg

Dextromethorphan HBr USP 15 mg

Doxylamine succinate USP 6.25 mg

When Using This Product, (When using this product,)

do not use more than directed.

Other Information Day Time (Other information - Day Time)
  • store at room temperature
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Other Information Night Time (Other information - Night Time)
  • store at room temperature
Inactive Ingredients Day Time (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 (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

When Using This Product Night Time (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 (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 (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.

Keep Out of Reach of Children.  Day Time (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.

If Pregnant Or Breast Feeding, Night Time (If pregnant or breast-feeding, - Night Time)

ask a health professional before use.

Keep Out of Reach of Children. Night Time (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.

Ask A Doctor Before Use If You Have Day Time (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 (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 (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 (Ask a doctor or pharmacist before use if you are - Night Time)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Package Label Principal Display Panel 16 Fl Oz (474 Ml Bottle) (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




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