Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 5791c1c7-f614-4940-a45a-6291742e1e22
Route
ORAL
Published
Effective Date 2024-09-17
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
Propylene Glycol Water Acesulfame Potassium Alcohol Anhydrous Citric Acid High Fructose Corn Syrup Polyethylene Glycol, Unspecified Saccharin Sodium Trisodium Citrate Dihydrate D&c Yellow No. 10 Fd&c Green No. 3 Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-31

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 these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • fever
    • sore throat
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • do not take more than directed  (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL= milliliter
  • keep dosing cup with product
    • adults and children 12 years and over: 30 mL every 6 hours
    • children under 12 years of age: do not use
  • When using other Day Time or Night Time products, carefully read each label to insure correct dosing
Do Not Use
  • with 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.
Product Label
WINCO Nighttime Multi-Symptom Cold and Flu Relief Original Flavor
Other Information
  • each 30 mL contains: potassium 5 mg
  • each 30 mL contain: sodium 19 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients

acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavor,  high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions Or Comments?

Call 800-824-1706 Monday-Friday 9am-4pm MST 

Principal Display Panel

*Compare to the active ingredients in VICK® NYQUIL® Cold & Flu

MULTI-SYMPTOM

Cold & Flu Relief

ACETAMINOPHEN 650 MG/

PAIN RELIEVER - FEVER REDUCER

DEXTROMETHORPHAN HBr 30 MG/

COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE 12.5 MG/

ANTIHISTAMINE

For Ages 12 Years & Over

Alcohol 10%

Nighttime

Original Flavor

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

WINCO FOODS, LLC,

BOISE, ID 83704

When Using This Product
  • 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 and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 7 days 
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • glaucoma
  • cough that occurs with to 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 an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are Taking
  • sedatives or tranquilizers
  • the blood thinning drug warfarin

Structured Label Content

Uses
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • fever
    • sore throat
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
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 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • do not take more than directed  (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • mL= milliliter
  • keep dosing cup with product
    • adults and children 12 years and over: 30 mL every 6 hours
    • children under 12 years of age: do not use
  • When using other Day Time or Night Time products, carefully read each label to insure correct dosing
Do Not Use (Do not use)
  • with 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.
Product Label
WINCO Nighttime Multi-Symptom Cold and Flu Relief Original Flavor
Other Information (Other information)
  • each 30 mL contains: potassium 5 mg
  • each 30 mL contain: sodium 19 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, alcohol, citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavor,  high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions Or Comments? (Questions or comments?)

Call 800-824-1706 Monday-Friday 9am-4pm MST 

Principal Display Panel

*Compare to the active ingredients in VICK® NYQUIL® Cold & Flu

MULTI-SYMPTOM

Cold & Flu Relief

ACETAMINOPHEN 650 MG/

PAIN RELIEVER - FEVER REDUCER

DEXTROMETHORPHAN HBr 30 MG/

COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE 12.5 MG/

ANTIHISTAMINE

For Ages 12 Years & Over

Alcohol 10%

Nighttime

Original Flavor

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

WINCO FOODS, LLC,

BOISE, ID 83704

When Using This Product (When using this product)
  • 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 and 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 
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • glaucoma
  • cough that occurs with to 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 an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)
  • sedatives or tranquilizers
  • the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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