ENTRE-COUGH- dextromethorphan hydrobromide, guaifenesin and pseudoephedrine hydrochloride liquid 
Acella Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients (in each 5 mL, 1 teaspoonful) Purpose
Dextromethorphan Hydrobromide 15 mgCough Suppressant
Pseudoephedrine Hydrochloride 30 mgNasal Decongestant
Guaifenesin 175 mgExpectorant

Uses

temporary relieves these symptoms due to the common cold, hay fever (allergic rhinitis] or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages.

Warnings

Do not exceed recommended dose.

Do not use

  • if you are 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before you take this product

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough accompanied by too much phlegm (mucous)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland.

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breastfeeding

  • 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. 800-222-1222

Directions

  • may be given every 8 hours. Do not take more than 3 doses in 24 hours unless directed by a doctor.
AgeDose
Adults and children over 12 years of age2 teaspoons every 8 hours
Children 6 to under 12 years of age1 teaspoon every 8 hours
Children under 6 years of ageAs directed by a physician

Other information

  • store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) .

Inactive ingredients

acesulfame K, aspartame, bitter mask, cherry flavor, citric acid, FD&C Red #40, glycerine, hydrochloric acid, magnesium aluminum silicate, methyl paraben, purified water, sodium benzoate, sodium citrate dihydrate, sodium hydroxide and xanthan gum.

Questions or comments

1-800-541-4802

Manufactured for

Acella Pharmaceuticals, LLC
Alpharetta, GA 30022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 473 mL

NDC 42192-523-16

Entre-Cough
Suspension

Cherry Flavor

SHAKE WELL

16 fl oz (473 mL)

Acella
PHARMACEUTICALS, LLC

Principal Display Panel - 473 mL
ENTRE-COUGH 
dextromethorphan hydrobromide, pseudoephedrine hydrochloride, guaifensin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42192-523
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN175 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ASPARTAME 
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
HYDROCHLORIC ACID 
MAGNESIUM ALUMINUM SILICATE 
METHYLPARABEN 
WATER 
SODIUM BENZOATE 
TRISODIUM CITRATE DIHYDRATE 
SODIUM HYDROXIDE 
XANTHAN GUM 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:42192-523-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/04/2013
Labeler - Acella Pharmaceuticals, LLC (825380939)

Revised: 02/2013
Document Id: cac6b61c-41db-4d19-9d69-972fab946287
Set id: 18b42a89-22b9-46d6-9a08-8642b7bbca5e
Version: 2
Effective Time: 20130205
 
Acella Pharmaceuticals, LLC