Night-time - 501

Night-time - 501
SPL v8
SPL
SPL Set ID eb24323f-82a1-4ba3-9359-fe81571c3fba
Route
ORAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Citric Acid Monohydrate D&c Yellow No. 10 Fd&c Green No. 3 Fd&c Yellow No. 6 Glycerin Polyethylene Glycol 400 Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Citrate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-10-01

Description

Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg  

Purpose

Pain reliever/fever reducer    Cough suppressant    Antihistamine  


Medication Information

Purpose



Pain reliever/fever reducer   



Cough suppressant   



Antihistamine  

Description

Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg  

Uses

temporarily relieves cold/flu symptoms:

  • sore throat
  • minor aches and pain
  • runny nose and sneezing
  • cough due to minor sore throat and bronchial irritation
  • headache
  • fever
Warnings

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

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

Allergy Alert:Acetaminophen may causesevere skin reactions. Symptoms may include:

  • skinreddening
  • blisters
  • rash

If a skin reactions occurs, stop 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.

Directions
  • take only as recommended-see Overdose warnings
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • If taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours

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 sleepy
Drug Facts

Acetaminophen 650 mg  

Dextromethorphan HBr 30 mg  

Doxylamine Succinate 12.5 mg  

Questions?

Call weekdays

1-877-798-5944

Overdose Warning

 Taking more than the recommended dose can cause serious health problems. 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.

Other Information
  • each 30 mL dose cup contains:
  • sodium 45 mg
  • store at room temperature
Inactive Ingredients

citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

When Using This Product
  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  •  redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, 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

Keep out of reach of children.

Ask A Doctor Before Use If You Have
  • a sodium restricted diet
  • 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
  • if you are taking the blood thinning drug warfarin
Market Basket Night Time Product Label

MARKET BASKET®

"MORE FOR YOUR DOLLAR"

* COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®



NIGHT-TIME

MULTI-SYMPTOM COLD/FLU  RELIEF





Acetaminophen - Pain Reliever/Fever Reducer



Dextromethorphan HBr - Cough Suppressant



Doxylamine Succinate - Antihistamine

Original Flavor

12 FL OZ (354 mL)



DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to followthese warnings could result in serious complications



*This product is not manufactured or distributed by Proctor & Gamble, distributor of Vicks® Nyquil®   LR-002



Made in the USA



DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.

875 EAST STREET - TEWKSBURY, MA 01876

LR - 034 REV 01



res


Structured Label Content

Uses

temporarily relieves cold/flu symptoms:

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



Pain reliever/fever reducer   



Cough suppressant   



Antihistamine  

Warnings

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

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

Allergy Alert:Acetaminophen may causesevere skin reactions. Symptoms may include:

  • skinreddening
  • blisters
  • rash

If a skin reactions occurs, stop 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.

Directions
  • take only as recommended-see Overdose warnings
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • If taking Night Time at night and Day Time during the day, limit total to 4 doses per 24 hours

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 sleepy
Drug Facts

Acetaminophen 650 mg  

Dextromethorphan HBr 30 mg  

Doxylamine Succinate 12.5 mg  

Questions?

Call weekdays

1-877-798-5944

Overdose Warning (Overdose warning)

 Taking more than the recommended dose can cause serious health problems. 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.

Other Information (Other information)
  • each 30 mL dose cup contains:
  • sodium 45 mg
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

citric acid, D and C yellow No. 10, FD and C Green No. 3, FD and C Yellow No. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

When Using This Product (When using this product)
  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  •  redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, 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)

Keep out of reach of children.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a sodium restricted diet
  • 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 (Ask a doctor or pharmacist before use)
  • if you are taking sedatives or tranquilizers
  • if you are taking the blood thinning drug warfarin
Market Basket Night Time Product Label (Market Basket Night-Time product label)

MARKET BASKET®

"MORE FOR YOUR DOLLAR"

* COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®



NIGHT-TIME

MULTI-SYMPTOM COLD/FLU  RELIEF





Acetaminophen - Pain Reliever/Fever Reducer



Dextromethorphan HBr - Cough Suppressant



Doxylamine Succinate - Antihistamine

Original Flavor

12 FL OZ (354 mL)



DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to followthese warnings could result in serious complications



*This product is not manufactured or distributed by Proctor & Gamble, distributor of Vicks® Nyquil®   LR-002



Made in the USA



DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.

875 EAST STREET - TEWKSBURY, MA 01876

LR - 034 REV 01



res


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)