Monday, 4 June 2012

Topcare Cough and Sore Throat



acetaminophen and dextromethorphan hydrobromide

Dosage Form: oral liquid
Topco Cough & Sore Throat Drug Facts

Active ingredient (in each 15 mL = 1 tablespoon)


Acetaminophen 500 mg


Dextromethorphan HBr 15 mg



Purpose


Pain reliever


Cough suppressant



Uses


  • temporarily relieves:

  • minor aches and pains

  • headache

  • sore throat

  • cough due to a cold


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 2 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.


Ask a doctor before use if you have


  • liver disease

  • cough that occurs with too much phlegm (mucus)

  • cough that lasts or is chronic such 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


  • 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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.



Directions


  • do not take more than directed (see Liver warning)







adults and


children 12 years


and over

  • take 2 tablespoons (TBSP) in dose cup provided every 6 hours as needed

  • do not take more than 8 tablespoons in 24 hours

children under 12 years
  • do not use this adult product in children under 12 years of age


Other information


  • each tablespoon contains: potassium 20 mg and sodium 8 mg

  • store at 20°-25°C (68°-77°F)


Inactive ingredients


acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose



Questions or comments?


1-888-423-0139



Principal Display Panel


Day Time


Non-Drowsy


Pain Relief


Cough & Sore Throat


See New Warnings Information


Pain Reliever – Cough Suppressant


Sore Throat, Body Aches/Headache – Acetaminophen


Coughing – Dextromethorphan HBr


Cool Ice®


Instant Cooling Sensation


Compare to Tylenol® Cough & Sore Throat active ingredients


Cough & Sore Throat Front Label



Cough & Sore Throat Back Label










Topcare Cough and Sore Throat 
acetaminophen, dextromethorphan hbr  liquid










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)36800-698
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





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBLUE (clear)Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
136800-698-34237 mL In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/10/2006


Labeler - Topco Associates LLC (006935977)
Revised: 08/2009Topco Associates LLC




More Topcare Cough and Sore Throat resources


  • Topcare Cough and Sore Throat Dosage
  • Topcare Cough and Sore Throat Use in Pregnancy & Breastfeeding
  • Topcare Cough and Sore Throat Drug Interactions
  • 0 Reviews for Topcare Cough and Sore Throat - Add your own review/rating


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