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Panatuss DXP

Dosage form: liquid
Ingredients: DEXBROMPHENIRAMINE MALEATE 2mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 20mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 5mL
Labeler: Seyer Pharmatec, Inc.
NDC Code: 11026-2675

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 FACTS


 Active Ingredients (in each 5 mL teaspoonful)                                                          Purpose

Dexbrompheniramine Maleate    2 mg............................................................................Antihistamine

Dextromethorphan HBr   20 mg...................................................................................Cough Suppressant

Phenylephrine HCl   10 mg........................................................................................Nasal Descongestant

 Uses

  •  Temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold.
  • Temporarily relieves nasal congestions due to common cold.
  • For temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or allergic rhinitis.


  Warnings:

Do not use: in child who is taking a prescription monoamine oxidase inhibitor (MAOI), (certain drugs for prescription, psychiatric, or emotional conditions, or Parkinson's Disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. May cause excitability especially in children. Do not take this product, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlarged of the prostate gland. May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcohol beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.


When using this product:

  • Use only as directed by physician


Stop use and ask a doctor if
  • Your child gets nervous, dizzy, or sleepless
  • Condition lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Do not use if pregnant or breast feeding

Directions

Take every 4 hours, not to exceed 6 doses in 24 hours or as directed by a physician

Adults and Children 12 years of age and older 1 teaspoonful

Children 6 to under 12 years of age 1/2 teaspoonful

Children under 6 years of age, only as directed by a physician



Other Information:

  • Warning: Phenylketonorics: Contains phenylalanine 7.5 mg per 5 mL
  • Store at 15-30 degrees celcius(59-86 degrees fahrenheit)
  • Alcohol Free and Phenylpropanolamine (PPA) Free
  • Any question or comments, please call toll-free: 1-888-782-3585
TAMPER-EVIDENT DISCLOSURE: Do not use this product if printed foil under cap is torn, broken or missing.

Inactive Ingredients

aspartame, D and C red 33, flavor, methylparaben, glycyrrhizinate, polyethylene glycol, propylene glycol, propylparaben, purified water, and sucrose.

Questions: Seyer Pharmatec, Inc. Guaynabo, Puerto Rico 00970



PANATUSS  DXP
dexbrompheniramine maleate, dextromethorphan, phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11026-2675
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (DEXBROMPHENIRAMINE) DEXBROMPHENIRAMINE MALEATE2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
D&C RED NO. 33 
METHYLPARABEN 
GLYCYRRHIZIN, AMMONIATED 
POLYETHYLENE GLYCOL 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SUCROSE 
Packaging
#Item CodePackage Description
1NDC:11026-2675-4118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2005
Labeler - Seyer Pharmatec, Inc. (832947126)
Registrant - Lex Inc. (046172888)
Establishment
NameAddressID/FEIOperations
Lex Inc.046172888manufacture

 
Seyer Pharmatec, Inc.

Medically reviewed on Jan 10, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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