DELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR- dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid

DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor by

Drug Labeling and Warnings

DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor by is a Otc medication manufactured, distributed, or labeled by Deliz Pharmaceutical Corp, Woodfield Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients(in each 5 mL teaspoonful)

Dexchlorpheniramine maleate, USP 1 mg
Dextromethorphan HBr, USP 15 mg
Pseudoephedrine HCl, USP 30 mg

Purpose

Antihistamine

Cough suppressant

Nasal Decongestant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• Temporarily restores freer breathing through the nose

Warnings

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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlarged prostrate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)
  

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• do not exceed recommended dosage
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• avoid alcoholic beverages
• use caution when driving a motor vehicle or operating machinery
• excitability may occur especially in children
  

Stop use and ask a doctor if

• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
• symptoms do not improve within 7 days or are accompanied by fever
• nervousness, dizziness, or sleeplessness occur
  

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.

Directions

• use only with enclosed measuring cup
• do not use enclosed measuring cup for any other drug product

• Adults and children 12 years of age and older: 2 teaspoonfuls (tsp) every 6 hours not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor.
• Children 6 to under 12 years of age: 1 teaspoonful (tsp) every 6 hours not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.
• Children 2 to under 6 years of age: Consult a doctor.

Other information

• Store at room temperature 15°C-30°C (59°F-86°F)
  

Inactive ingredients

Bitter Mask, Citric Acid Anhydrous, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions?

Call 1-787-701-3312. You may also report serious side effects to this phone number.

Product Labels

INGREDIENTS AND APPEARANCE

DELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR 
dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58238-225
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N)	DEXCHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58238-225-04	1 in 1 CARTON	03/20/2015
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/20/2015

Labeler - Deliz Pharmaceutical Corp (826391138)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceutical, LLC		079398730	manufacture(58238-225)