PANATUSS 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., Lex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

  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.

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

Do not use if pregnant or breast feeding

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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 INGREDIENT

Inactive Ingredients

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PANATUSS  DXP
dexbrompheniramine maleate, dextromethorphan, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11026-2675
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 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: 11026-2675-4	118 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 - Lex Inc. (046172888)

Establishment
Name	Address	ID/FEI	Business Operations
Lex Inc.		046172888	manufacture