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  5. Label Information: Nighttime Cold And Flu Relief

FDA Label for Nighttime Cold And Flu Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH LIQUID CAP)
    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. PRINCIPAL DISPLAY PANEL

Nighttime Cold And Flu Relief Product Label

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

Active Ingredients (In Each Liquid Cap)



Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


Purpose



Pain reliever/fever reducer

Cough suppressant

Antihistamine


Uses



temporarily relieves common cold and flu symptoms:

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

Warnings



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

  • more than 8 liquid caps 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.


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
  • trouble urinating due to an enlarged prostate gland
  • 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

Ask A Doctor Or Pharmacist Before Use If You Are



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

When Using This Product



  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery  

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.


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 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



  • do not take more than directed (see overdose warning)
  • do not take more than 8 liquid caps in 24 hours
  • adults and children 12 years and over: take 2 liquid caps with water every 6 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause   liver damage.

Other Information



  • store at controlled room temperature 15°C to 30°C (59°F to 86°F)
  • see end flap for expiration date and lot number

Inactive Ingredients



D&C yellow #10*, edible ink, FD&C blue #1*, FD&C green #3*, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, * contains one or more of these ingredients


Questions Or Comments?



1-800-706-5575


Principal Display Panel



MULTI-SYMPTOM NIGHTTIME

Cold & Flu Relief

Acetaminophen / Aches / Fever / Sore throat

Dextromethorphan HBr / Cough

Doxylamine Succinate / Sneezing / Runny Nose

Compare to Vicks® NyQuil® active ingredients‡

nighttime-16ct-ctn - nighttime 16ct ctn

nighttime-16ct-ctn - nighttime 16ct ctn


* Please review the disclaimer below.