Nite Time 501

Nite Time 501
SPL v8
SPL
SPL Set ID fcd24753-b42b-4d05-8379-0ec0351ab217
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 Water Saccharin Sodium Sodium Benzoate Sodium Citrate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-01-16

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
Section 55106-9



Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg  

Warnings

Failure to follow these warnings could result in serious consequences



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 amoun

    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks
  • every day while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include

  • skin reddening
  • blisters
  • rash

If a skin reaction ccurs, stop use 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 Nite 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
Product Label

Compare to VICKS® NYQUIL® active ingredients    CVP CONSUMER VALUE PRODUCTS



Nite-Time COLD/FLU Medicine

Multi-Symptom ORIGINAL FLAVOR



Acetaminophen ..........................Aches, Fever and Sore Throat



Dextromethorphan ......................Cough



Doxylamine Succinate ................Sneezing, Runny nose



6 FL OZ (177 mL)



DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN




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



Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944



Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503   www.saladosales.com



LOT:        EXP:



Peel Here  DRUG FACTS CONTINUED ON BACK



ORIGINAL FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine

  •  Antihistamine
  • Cough Suppressant
  • Pain Reliever
  • Fever Reducer

res

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
Pregnant Or Breast Feeding

ask a health professional before use.

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
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

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
Section 55106-9 (55106-9)



Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg  

Purpose



Pain reliever/fever reducer  

Cough suppressant  

Antihistamine  

Warnings

Failure to follow these warnings could result in serious consequences



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 amoun

    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks
  • every day while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include

  • skin reddening
  • blisters
  • rash

If a skin reaction ccurs, stop use 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 Nite 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
Product Label

Compare to VICKS® NYQUIL® active ingredients    CVP CONSUMER VALUE PRODUCTS



Nite-Time COLD/FLU Medicine

Multi-Symptom ORIGINAL FLAVOR



Acetaminophen ..........................Aches, Fever and Sore Throat



Dextromethorphan ......................Cough



Doxylamine Succinate ................Sneezing, Runny nose



6 FL OZ (177 mL)



DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN




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



Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944



Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503   www.saladosales.com



LOT:        EXP:



Peel Here  DRUG FACTS CONTINUED ON BACK



ORIGINAL FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine

  •  Antihistamine
  • Cough Suppressant
  • Pain Reliever
  • Fever Reducer

res

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 (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
Pregnant Or Breast Feeding (Pregnant Or Breast-Feeding)

ask a health professional before use.

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
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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)