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  5. Label Information: Night Time Gelcap

FDA Label for Night Time Gelcap

View Indications, Usage & Precautions

Table of Contents

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

Night Time Gelcap Product Label

The following document was submitted to the FDA by the labeler of this product Kareway Product, 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 Gelcap)



Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg


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 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 phegm(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



Enter section text here


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



Enter section text here


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.  Quick medical attention is critical to adults and 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 and children 12 yrs and over
    		2 GelCaps with water every 6 hrs
    children 4 to under 12 yrs
    		ask a doctor
    children under 4 yrs
    		do not use

Other Information



  • store at room temperature

Inactive Ingredients



FDC yellow no. 5, dioxide, FDC blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sobital special


Package Label.Principal Display Panel



Pure-Aid Nighttime Gelcap

image of carton - nighttime.carton2

image of carton - nighttime.carton2


* Please review the disclaimer below.