SPL v1
SPL
SPL Set ID fc39b8dd-a4bd-4b40-accf-edd248a0b4fa
Route
ORAL
Published
Effective Date 2013-05-03
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 NOT FINAL Active Since 2012-09-01

Description

Drug Facts Active ingredients (in each 30 mL dose cup) 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

Drug Facts Active ingredients (in each 30 mL dose cup) Acetaminophen 650 mg    Dextromethorphan HBr 30 mg    Doxylamine Succinate 12.5 mg

Uses

temporarily relieves cold/flu symptoms:

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

 



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



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
Questions?

Call weekdays



1-877-798-5944

Product Label

NDC 68016-144-01

COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®



Premier Value®



Original



Night-Time

MULTI-SYMPTOM COLD/FLU RELIEF



Acetaminophen……Pain Reliever/Fever Reducer

Dextromethorphan HBr……Cough Suppressant

Doxylamine Succinate ……………Antihistamine



12 FL OZ (354 mL)

INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV



DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING



*This product is not manufactured or distributed by Procter and Gamble, owner of the registered trademark Vicks® NyQuil®



If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.



DISTRIBUTED BY

CHAN DRUG CONSORTIUM

3301 NW BOCO RATON BLVD

SUITE 101, BOCA RATON FL 33431

LR-024

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
Active Ingredients

Drug Facts



Active ingredients (in each 30 mL dose cup)




Acetaminophen 650 mg   



Dextromethorphan HBr 30 mg   



Doxylamine Succinate 12.5 mg

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

Structured Label Content

Uses

temporarily relieves cold/flu symptoms:

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

 



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



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
Questions?

Call weekdays



1-877-798-5944

Product Label

NDC 68016-144-01

COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®



Premier Value®



Original



Night-Time

MULTI-SYMPTOM COLD/FLU RELIEF



Acetaminophen……Pain Reliever/Fever Reducer

Dextromethorphan HBr……Cough Suppressant

Doxylamine Succinate ……………Antihistamine



12 FL OZ (354 mL)

INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV



DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING



*This product is not manufactured or distributed by Procter and Gamble, owner of the registered trademark Vicks® NyQuil®



If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.



DISTRIBUTED BY

CHAN DRUG CONSORTIUM

3301 NW BOCO RATON BLVD

SUITE 101, BOCA RATON FL 33431

LR-024

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
Active Ingredients (Active ingredients)

Drug Facts



Active ingredients (in each 30 mL dose cup)




Acetaminophen 650 mg   



Dextromethorphan HBr 30 mg   



Doxylamine Succinate 12.5 mg

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

Advanced Ingredient Data


Raw Label Data

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