1. Home
  2. Labeler Index
  3. Wal-mart Stores Inc
  4. 49035-978
  5. Label Information: Nitetime Cold/flu, Multi-symptom Relief

FDA Label for Nitetime Cold/flu, Multi-symptom Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. QUESTIONS OR COMMENTS?
    9. PRINCIPAL DISPLAY PANEL

Nitetime Cold/flu, Multi-symptom Relief Product Label

The following document was submitted to the FDA by the labeler of this product Wal-mart Stores 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 Ingredient (In Each Softgel)



Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg 


Purposes



Pain reliever/fever reducer

Cough suppressant

Antihistamine


Uses



temporarily relieves common cold/flu symptoms:

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

Warnings



Liver warning

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

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

    • Sore throat warning

    If sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

    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.


Directions



  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hrs                                                                   

    • adults & children 12 yrs & over

    2 softgels with water every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

    when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing


Other Information



store at room temperature 15°-30°C (59°-86°F)


Inactive Ingredients



D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink


Questions Or Comments?



1-888-287-1915


Principal Display Panel



equate NiteTime Cold & Flu Multi-Symptom Relief

NDC 49035-978-04

24 Softgels


* Please review the disclaimer below.