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  5. Label Information: Daytime Non-drowsy Cold/flu

FDA Label for Daytime Non-drowsy Cold/flu

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTSACTIVE INGREDIENTS (IN EACH 15 ML, 1 TABLESPOON)
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE ASK A DOCTOR OR PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OF BREAST-FEEDING
    11. OVERDOSE WARNING:
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. DAY TIME PRODUCT LABEL

Daytime Non-drowsy Cold/flu Product Label

The following document was submitted to the FDA by the labeler of this product Salado Sales, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Factsactive Ingredients (In Each 15 Ml, 1 Tablespoon)



Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCL 5 mg


Purpose



     Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant


Keep Out Of Reach Of Children



Keep this and all drugs out of the reach of children.


Uses



Uses

  • temporarily relieves these common cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • fever
  • nasal congestion
  • cough due to minor throat and bronchial irritation

Warnings



Warnings


Liver warning:

This product contains acetaminophen. Severe liver damage may occur if adult/child takes

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday while using this product

    • Allergy Alert

    Acetaminophen may cause severe 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 followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly


Do Not Use



Do not use

  • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.

Ask A Doctor Before Use If You Have Ask A Doctor Or Pharmacist



Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)


    • Ask a doctor or pharmacist before use

    if the user is taking the blood thinning drug warfarin


When Using This Product



When using this product

  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks

Stop Use And Ask A Doctor If



Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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 Of Breast-Feeding



ask a health professional before use.


Overdose Warning:



Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



Directions

  • take only as recommended (see overdose warning)
  • use dosage cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours




    • age                                                                                                         dose


    adults and children 12 years and over                                                        30 mL (2 TBSP) every 4 hours


    children 6 years to under 12 years                                                             15 mL (1 TBSP) every 4 hours


    children 4 years to  under 6 years                                                              ask a doctor


    children under 4 years                                                                                do not use

    • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

Other Information



Other information

  • sodium content per tablespoon: 10 mg
  • store at room temperature

Inactive Ingredients



 citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose


Questions?



 Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944


Day Time Product Label



*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®
DAYQUIL ®

CVP
CONSUMER VALUE PRODUCTS

DAYTIME

NON-DROWSY COLD/FLU RELIEF

Acetaminophen……Pain Reliever/Fever Reducer
Dextromethorphan HBr……Cough Suppressant
Phenylephrine HCL ……. Nasal Decongestant

6 FL OZ (177 mL)

Failure to follow these warnings could result in serious consequences

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark Vicks® Dayquil®.

LR-038 Rev 02

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

LOT:       EXP:


* Please review the disclaimer below.