FDA Label for Daytime Cold And Flu

View Indications, Usage & Precautions

Daytime Cold And Flu Product Label

The following document was submitted to the FDA by the labeler of this product Humanwell Puracap Pharmaceutical (wuhan), Ltd.. 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 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Purpose



Pain reliever/ fever reducer

Cough suppressant 

Nasal decongestant


Uses



temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • nasal congestion
  • 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 in 24 hours, 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, persists more than 2 days, occurs with or is 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
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an 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


When Using This Product



  • do not use more than directed

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.

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 for adults and 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 and children 12 years of age and older

     take 2 softgels with water every 4 hours

    children 4 to under 12 years of age

     ask a doctor

    children under 4 years of age

     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



FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei 430206,
China


Principal Display Panel - Shipping Label



DayTime Cold and Flu Capsules
Quantity : 4000 Capsules
NDC. No : 53345-025-01

IMPORTANT:

  • Inspect immediate upon receipt.
  • This is a bulk shipment intended for further processing only.
  • Protect from heat, humidity, and light. Do not refrigerate.
  • Store at 15-30°C (59-86°F) 
  • CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING"


* Please review the disclaimer below.