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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. DRUG FACTS
    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 - 16 CPSULES BOTTLE

Nighttime Cold And Flu Relief Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. 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 Facts



Active ingredients (in each capsule)

Acetaminophen USP 325 mg
Dextromethorphan HBr USP 15 mg
Doxylamine succinate USP 6.25 mg


Purpose



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 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

Ask A Doctor Or Pharmacist Before Use If You Are



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

When Using This Product



  • do not use more than directed
  • 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, & 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.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



Overdose warning:

Taking more than directed can cause serious health problems. 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 & for children even if you do not notice any signs or symptoms.


Directions



  • take only as directed – see Overdose warning
  • do not exceed 4 doses per 24 hours

    • adults & children 12 yrs & over
    		2 capsules with water every 6 hrs
    children 4 to under 12 yrs
    		ask a doctor
    children under 4 yrs
    		do not use

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


Other Information



  • store at room temperature

Inactive Ingredients



D&C Yellow No. 10, gelatin, glycerin, Neelicert FD&C Blue No. 1, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide


Questions Or Comments?



call 1-855-274-4122
 
Distributed by:
Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, Pa 19087



Package Label-Principal Display Panel - 16 Cpsules Bottle



NDC 68016-878-16

Premier Value®


COMPARE TO THE ACTIVE INGREDIENTS
IN VICKS® NYQUIL® COLD & FLU
NIGHTTIME RELIEF LIQUICAPS®

Multi-Symptom

Nighttime
COLD & FLU RELIEF

Acetaminophen, Dextromethorphan HBr and

Doxylamine Succinate Capsules

325 mg/15 mg/6.25 mg 


* Please review the disclaimer below.