PANATUSS PEDIATRIC DROPS DXP- dexbrompheniramine maleate, dextromethorphan, phenylephrine liquid

Panatuss by

Drug Labeling and Warnings

Panatuss by is a Otc medication manufactured, distributed, or labeled by Seyer Pharmatec, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

 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

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

  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.

DO NOT USE

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 REACH OF CHILDREN

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, consult a doctor.

DOSAGE & ADMINISTRATION

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.
  

INDICATIONS & USAGE

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 INGREDIENT

Inactive Ingredients

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

QUESTIONS

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

Seyer Pharmatec, Inc. Guaynabo, Puerto Rico 00970

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PANATUSS  PEDIATRIC DROPS DXP
dexbrompheniramine maleate, dextromethorphan, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11026-2662
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	0.5 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11026-2662-2	60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/01/2005

Labeler - Seyer Pharmatec, Inc. (832947126)

Registrant - Seyer Pharmatec, Inc. (832947126)