FDA Label for Nighttime Cold And Flu

View Indications, Usage & Precautions

Nighttime 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 15 mg

Doxylamine Succinate 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 hours, which is the maximum daily amount
  • 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


Otc - Do Not Use



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 with excessive phlegm(mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • difficulty in urinating due to an 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 exceed the recommended dosage
  • do not use for more than 7 days
  • excitability may occur especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as 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 over

     Swallow 2 softgels with water every 6 hours

    Children 4 to 12 years of age

     ask a doctor

    children under4 years o9f age

    do not use

    If taking NIGHTTIME and DAYTIME softgels carefully read each label to insure correct dosing.


Other Information



  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • this product does not contain phenylpropanolamine (PPA)

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

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


Principal Display Panel - Shipping Label



NIGHTTIME COLD AND FLU CAPSULES

Quantity : 4000 Capsules
NDC. No : 53345-006-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"


* Please review the disclaimer below.