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  5. Label Information: Daytime Cold And Flu Multi-symptom Relief

FDA Label for Daytime Cold And Flu Multi-symptom Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPSULE)
    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. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. OTC - QUESTIONS
    15. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - (16 CAPSULES BOTTLE)

Daytime Cold And Flu Multi-symptom Relief Product Label

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

Active Ingredients (In Each Capsule)



Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Phenylephrine HCl USP 5 mg


Purpose



Pain reliever/fever reducer
Cough suppressant
Nasal decongestant


Uses



temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Warnings



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

  • more than 4 doses 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.

Ask A Doctor Before Use If You Have



  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are



taking the blood thinning drug warfarin.


Stop Use And Ask A Doctor If



  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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 hrs

    • adults & children 12 yrs & over
    		2 capsules with water every 4 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



citric acid anhydrous, gelatin, glycerin, Neelicert FD & C Red No. 40, Neelicert FD & C Yellow No. 6 noncrystallizing sorbitol solution, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, titanium dioxide

Questions or comments?

call 1-855-274-4122


Otc - Questions



Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648


Package Label-Principal Display Panel - (16 Capsules Bottle)



AUROHEALTH
NDC 58602-768-15
Compare to the active ingredients
in VICKS® DayQuil® Cold & Flu
Multi-Symptom Relief LiquiCaps®*

Multi-Symptom Relief
Non-Drowsy
Daytime Relief
Cold & Flu
Acetaminophen, Dextromethorphan HBr and
Phenylephrine HCl Capsules
325 mg/10 mg/5 mg

* Please review the disclaimer below.