Panatuss

Seyer Pharmatec, Inc.
Lex Inc.

DRUG FACTS

FULL PRESCRIBING INFORMATION

Active ingredient

 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

Purpose

 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.

• Use only as directed by physician

• 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

Uses

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

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 Dexbrompheniramine Maleate, Dextromethorphan, Phenylephrine LIQUID Product Information Product Type Human otc drug label Item Code (Source) NDC:11026-2675 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dexbrompheniramine Maleate DEXBROMPHENIRAMINE 2 mg DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 20 mg Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg Inactive Ingredients Ingredient Name Strength ASPARTAME D&C RED NO. 33 METHYLPARABEN GLYCYRRHIZIN, AMMONIATED polyethylene glycol propylene glycol PROPYLPARABEN water SUCROSE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11026-2675-4 118 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part341 2005-09-01