ENTRE-COUGH- dextromethorphan hydrobromide, pseudoephedrine hydrochloride, guaifensin 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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Entre-Cough Suspension

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

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

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
Liquid

Cherry Flavor

16 fl oz (473 mL)

Acella
PHARMACEUTICALS, LLC

ENTRE-COUGH
dextromethorphan hydrobromide, pseudoephedrine hydrochloride, guaifensin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42192-523
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	175 mg in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42192-523-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2013	07/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/30/2013	07/31/2016

Labeler - Acella Pharmaceuticals, LLC (825380939)

Name	Address	ID/FEI	Business Operations
Establishment
Acella Pharmaceuticals, LLC		825380939	manufacture(42192-523)

Revised: 9/2018

Document Id: 42928202-e509-4a3b-ad18-eed760cace4a

Set id: 18b42a89-22b9-46d6-9a08-8642b7bbca5e

Version: 6

Effective Time: 20180912

Acella Pharmaceuticals, LLC