nighttime cold and flu

nighttime cold and flu
SPL v3
SPL
SPL Set ID 1deb60f3-e9be-4756-b0c1-527ef00dc741
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 (15 mg) doxylamine (6.25 mg)
Inactive Ingredients
d&c yellow no. 10 gelatin, unspecified glycerin fd&c blue no. 1 polyethylene glycol, unspecified povidone, unspecified propylene glycol water shellac sorbitol titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: Q07 Shape: oval Color: green Size: 20 mm Score: 1
Marketing Status
otc monograph drug active Since 2019-07-12

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Description

Active ingredients (in each capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 15 mg Doxylamine succinate USP 6.25 mg


Medication Information

Warnings

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.

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Directions
  • 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
  • store at room temperature
Inactive Ingredients

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

Description

Active ingredients (in each capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 15 mg Doxylamine succinate USP 6.25 mg

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.
  • to make a child sleep
Drug Facts

Active ingredients (in each capsule)



Acetaminophen USP 325 mg

Dextromethorphan HBr USP 15 mg

Doxylamine succinate USP 6.25 mg

Questions Or Comments?

call 1-855-274-4122

 

Distributed by :

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, Pa 19087



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, & tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • 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.

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 (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
  • 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
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Package Label Principal Display Panel  16 Cpsules Bottle

NDC 68016-878-16

Premier Value ®



COMPARE TO THE ACTIVE INGREDIENTS

IN VICKS® NYQUIL® COLD & FLU

NIGHTTIME RELIEF LIQUICAPS®

Multi-Symptom

Nighttime

COLD & FLU RELIEF

Acetaminophen, Dextromethorphan HBr and

Doxylamine Succinate Capsules

325 mg/15 mg/6.25 mg 



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

16 Capsules




Structured Label Content

Warnings

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.

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing
Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Directions
  • 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 (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

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

Do Not Use (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.
  • to make a child sleep
Drug Facts

Active ingredients (in each capsule)



Acetaminophen USP 325 mg

Dextromethorphan HBr USP 15 mg

Doxylamine succinate USP 6.25 mg

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122

 

Distributed by :

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, Pa 19087



When Using This Product (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, & tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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, (If pregnant or breast-feeding,)

ask a health professional before use.

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 (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 (Ask a doctor before use if you have)
  • 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 (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
Package Label Principal Display Panel  16 Cpsules Bottle (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 16 Cpsules Bottle)

NDC 68016-878-16

Premier Value ®



COMPARE TO THE ACTIVE INGREDIENTS

IN VICKS® NYQUIL® COLD & FLU

NIGHTTIME RELIEF LIQUICAPS®

Multi-Symptom

Nighttime

COLD & FLU RELIEF

Acetaminophen, Dextromethorphan HBr and

Doxylamine Succinate Capsules

325 mg/15 mg/6.25 mg 



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

16 Capsules




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