Wednesday, 16 May 2012

Nitetime Oral Liquid





Dosage Form: oral liquid
Publix Super Markets, Inc. NiteTime Cold/Flu Relief Liquid Drug Facts

Active ingredient (in each 15 mL tablespoon)


Acetaminophen 500 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 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 hours, which is the maximum daily amount

  • with other drugs containing acetaminophen

  • 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or 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.

  • to make a child sleepy


Ask a doctor before use if you have


  • liver disease

  • glaucoma

  • cough that occurs with too much phlegm (mucus)

  • a breathing problem such as emphysema or chronic bronchitis

  • trouble urinating due to an enlarged prostate gland

  • persistent or chronic cough as occurs with smoking, asthma or emphysema

  • a sodium-restricted diet


Ask a doctor or pharmacist before use if you are


  • taking sedatives or tranquilizers

  • taking the blood thinning drug warfarin


When using this product


  • 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 and 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.


In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.



Directions


  • take only as recommended – see Liver warning

  • use dose cup

  • do not exceed 4 doses per 24 hours








adults and children 12 years and over30 mL (2 TBSP) every 6 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing


Other information


  • each TBSP contains: sodium 18 mg

  • store at 20°-25°C (68°-77°F)


Inactive ingredients


alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate



Principal Display Panel


See New Warnings Information


Original Flavor


NiteTime


Acetaminophen – Aches, Fever


Dextromethorphan HBr – Cough


Doxylamine Succinate – Sneezing, Runny Nose


Antihistamine, Cough Suppressant, Fever Reducer, Pain Reliever


Multi-Symptom


Cold/Flu Relief


Alcohol 10%


Compare to Active Ingredients in NyQuil®


Nite Time Cold/Flu Relief Liquid Label










NITETIME 
acetaminophen,dextromethorphan hbr, doxylamine succinate  liquid










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)56062-908
Route of AdministrationORALDEA Schedule    














Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN)ACETAMINOPHEN500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE)DOXYLAMINE SUCCINATE6.25 mg  in 15 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorGREEN (Bright)Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
156062-908-38296 mL In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2006


Labeler - Publix Super Markets Inc (006922009)
Revised: 05/2009Publix Super Markets Inc




More Nitetime Oral Liquid resources


  • Nitetime Oral Liquid Side Effects (in more detail)
  • Nitetime Oral Liquid Use in Pregnancy & Breastfeeding
  • Nitetime Oral Liquid Drug Interactions
  • Nitetime Oral Liquid Support Group
  • 0 Reviews for Nitetime Oral - Add your own review/rating


Compare Nitetime Oral Liquid with other medications


  • Cough
  • Pain

No comments:

Post a Comment