Entre-Cough description, usages, side effects, indications, overdosage, supplying and lots more!

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Entre-Cough

Acella Pharmaceuticals, LLC

Entre-Cough Suspension


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients (in each 5 mL, 1 teaspoonful) Purpose
Dextromethorphan Hydrobromide 15 mg Cough Suppressant
Pseudoephedrine Hydrochloride 30 mg Nasal Decongestant
Guaifenesin 175 mg Expectorant

Entre-Cough 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.
Age Dose
Adults and children over 12 years of age 2 teaspoons every 8 hours
Children 6 to under 12 years of age 1 teaspoon every 8 hours
Children under 6 years of age As directed by a physician

Entre-Cough 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

Active ingredient

Purpose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 473 mL

NDC 42192-523-16

Entre-Cough
Liquid

Cherry Flavor

16 fl oz (473 mL)

Acella
PHARMACEUTICALS, LLC

Entre-Cough

Entre-Cough

Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, Guaifensin LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42192-523
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
Guaifenesin GUAIFENESIN 175 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42192-523-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-02-04


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Be sure to consult your doctor before taking any medication!
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