Panatuss Pediatric Drops DXP

Dosage form: liquid
Ingredients: DEXBROMPHENIRAMINE MALEATE 0.5mg in 1mL, DEXTROMETHORPHAN HYDROBROMIDE 5mg in 1mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1mL
Labeler: Seyer Pharmatec, Inc.
NDC Code: 11026-2662

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 (per 1 mL)                                                          Purpose

Dexbrompheniramine Maleate   0.5 mg............................................................................Antihistamine

Dextromethorphan HBr   5 mg...................................................................................Cough Suppressant

Phenylephrine HCl   2.5 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, glaucoma, heart disease, high blood pressure, diabetes, or thyroid disease, unless directed by a doctor. May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.


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.

If pregnant or breast feeding, consult a doctor.

Directions

  • To be taken by mouth only. Not for nasal use.
  • Children 6 years of age to under 12 years; 2 mL every 4 - 6 hours.
  • Children under 6 years of age: Consult a doctor.
  • Do not exceed 4 doses in 24 hours.



Other Information:

  • Warning: Phenylketonorics contains phenylalanine 1.5 mg per 1 mL
  • Store at 15-30 degrees celcius(59-86 degrees fahrenheit)
  • Alcohol Free and Phenylpropanolamine (PPA) Free
  • Wrapped calibrated syringe (enclosed)
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, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, propylparaben, purified water, and sucrose.

Any questions or comments please call: (888) 782 - 3585

Seyer Pharmatec, Inc. Guaynabo, Puerto Rico 00970



PANATUSS  PEDIATRIC DROPS DXP
dexbrompheniramine maleate, dextromethorphan, phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11026-2662
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (DEXBROMPHENIRAMINE) DEXBROMPHENIRAMINE MALEATE0.5 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 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:11026-2662-260 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 - Seyer Pharmatec, Inc. (832947126)

Revised: 01/2012
 
Seyer Pharmatec, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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