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  5. Label Information: Kroger Nighttime Cold And Flu Relief

FDA Label for Kroger Nighttime Cold And Flu Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. SORE THROAT WARNING
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSE WARNING
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS?
    18. PRINCIPAL DISPLAY PANEL - 236 ML BOTTLE LABEL

Kroger Nighttime Cold And Flu Relief Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. 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.

Other



Drug Facts


Otc - Purpose



Active ingredients (in each 30 mL dose cup)Purpose

Acetaminophen 650 mg

Pain reliever/fever reducer

Dextromethorphan HBr 30 mg

Cough suppressant

Doxylamine succinate 12.5 mg

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

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

Sore Throat Warning



If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
  • ▪to make a child sleep

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 that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • ▪trouble urinating due to 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



  • ▪pain or cough gets worse or lasts more than 7 days
  • ▪fever gets worse or lasts more than 3 days
  • ▪redness or swelling is present
  • ▪new symptoms occur
  • ▪cough comes back or occurs with rash or headache that lasts.

    • These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 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.


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.


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, xanthan gum


Questions?



1-800-467-2748


Principal Display Panel - 236 Ml Bottle Label



Compare to the active ingredients in Vicks® NyQuil™ Cold & Flu Nighttime Relief*

NDC# 30142-629-12

Nighttime Cold & Flu Relief

Acetaminophen, Doxylamine,

Dextromethorphan HBr

  • •Headaches, Fever & Sore Throat
  • •Minor Aches & Pains
  • •Sneezing, Runny Nose
  • •Cough

    • Natural Cherry Flavor

    12 FL. OZ. (354 mL)

    Distributed by:

    *This product is not manufacturing or distributed by Procter & Gamble, the distributor of Vicks® NyQuil™ Cold & Flu Nighttime Relief.

    Kroger Nighttime Cold & Flu Relief - nyquil 01

    Kroger Nighttime Cold & Flu Relief - nyquil 01


* Please review the disclaimer below.