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  5. Label Information: Meijer Nitetime Cold And Flu Relief

FDA Label for Meijer Nitetime Cold And Flu Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 30 ML)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Meijer Nitetime Cold And Flu Relief Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution 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.

Active Ingredients (In Each 30 Ml)



Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg


Purpose



Pain reliever/fever reducer

Cough suppressant

Antihistamine


Uses



temporarily relieves common cold/flu symptoms:

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

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 for this product
  • •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 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



  • ▪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.

Ask A Doctor Before Use If You Have



  • ▪liver disease
  • ▪glaucoma
  • ▪cough that occurs with too much phlegm (mucus)
  • ▪a breathing problem or chronic cough as occurs with smoking, asthma, or emphysema
  • ▪trouble urinating due to an enlarged prostate gland
  • ▪a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are



  • ▪taking sedatives or tranquilizers
  • ▪taking the blood thinning drug warfarin

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



  •  

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



  • •take only as directed
  • •only use the dose cup provided
  • •do not exceed 4 doses per 24 hrs

    • adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use


Other Information



  • •each 30 mL contains: sodium 16 mg
  • •store at room temperature and do not refrigerate

Inactive Ingredients



anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose.


Questions Or Comments?



1-866-467-2748


Package/Label Principal Display Panel



Compare to the active ingredients in VICKS® Nyquil™COLD & FLU NIGHTTIME RELIEF*

Nitetime

Cold & Flu

Relief

PAIN RELIEVER/FEVER REDUCER, COUGH SUPPRESSANT

ANTIHISTAMINE

Acetaminophen,

Dextromethorphan HBr,

Doxylamine Succinate

RELIEVES: HEADACHE, FEVER, SORE THROAT

MINOR ACHES & PAINS

SNEEZING, RUNNY NOSE, COUGH

Mixed Berry

Naturally and Artificially Flavored

12 FL OZ (354 mL)

DIST. BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® Nyquil™COLD & FLU Nighttime Relief*


* Please review the disclaimer below.