DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor description, usages, side effects, indications, overdosage, supplying and lots more!

DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor

Deliz Pharmaceutical Corp

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor


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 runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever (allergic rhinitis)
  • temporarily restores freer breathing through the nose

Warnings


Do not use 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

  • 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 thank 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

citric acid, FDandC Blue 1, FDandC Red  40, glycerin, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose

Questions?

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

DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor 4oz/118ml (58238-225-04)

DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor 4oz/118ml (58238-225-04) 
DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor 4oz/118ml (58238-225-04)

DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor

DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58238-225
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Dexchlorpheniramine Maleate DEXCHLORPHENIRAMINE 1 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 15 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
METHYLPARABEN
AMMONIUM GLYCYRRHIZATE
POTASSIUM CITRATE
POTASSIUM SORBATE
PROPYLPARABEN
propylene glycol
water
sorbitol
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:58238-225-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-02-27


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Be sure to consult your doctor before taking any medication!
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