Label: DELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR- dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 58238-225-04 - Packager: Deliz Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 2, 2021
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients(in each 5 mL teaspoonful)
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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
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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)
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
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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
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
DELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR
dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquidProduct 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)
