ROMPE PECHO SF FLU- dextromethorphan, brompheniramine maleate, phenylephrine hydrochloride liquid

Rompe Pecho by

Drug Labeling and Warnings

Rompe Pecho by is a Otc medication manufactured, distributed, or labeled by Efficient Laboratories Inc, Pharmalab Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each 5 mls tsp.)                          Purpose

Dextromethorphan HBr 10 mg ........................... Cough Suppressant

Brompheniramine Maleate 4 mg ................................. Antihistaminic

Phenylephrine HCl 10 mg ................................. Nasal Decongestant

PURPOSE

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

INDICATIONS & USAGE

USES

• temporarily relieves runny nose, sneezing, itching of the nose or throat and itchy watery eyes due to hay fever or other upper respiratory allergies
• temporarily relieves cough and nasal congestion as may occur with the common cold

WARNINGS

Warnings

Do not exceed recommended dosage

Do not use If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product.

DO NOT USE

Ask a doctor before use if you have heart disease glaucoma high blood pressure thyroid disease diabetes difficulty in urination due to an enlarged prostate gland a persistent or chronic cough such as occurs with smoking, asthma or emphysema  a cough that is accompanied by excessive phlegm (mucus)  a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives
or tranquilizers.

When using this product  may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children.

Stop use and ask a doctor if symptoms do not improve within 7 days, cough tends to recur, or symptoms are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.  if nervousness, dizziness, or sleeplessness occur

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions:

• shake well before use
• do not exceed more than 6 doses in any 24-hour period or as directed by a doctor

                      Age                                                                  Dose

adults and children 12 years of age and over      5 mL (1 tsp) every 4 hours

children 6 to under 12 years of age                     2.5 mL (1/2 tsp) every 4 hours

children under 6 years of age                          consult a doctor

INACTIVE INGREDIENT

Inactive Ingredients:

Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerine, Golden Seal Root extract,
Honey Flavor, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein Leaf extract, Myrrh gum extract, Potassium Citrate,
Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract, Zinc Sulfate.

QUESTIONS

Questions or Comments?

305-805-3456 Monday - Friday 9AM to 5PM EST

www.efficientlabs.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROMPE PECHO  SF FLU
dextromethorphan, brompheniramine maleate, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-225
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
GINKGO (UNII: 19FUJ2C58T)
GOLDENSEAL (UNII: ZW3Z11D0JV)
HONEY (UNII: Y9H1V576FH)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
VERBASCUM DENSIFLORUM LEAF (UNII: 9936O846LI)
MYRRH (UNII: JC71GJ1F3L)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
ZINC SULFATE (UNII: 89DS0H96TB)
HOREHOUND (UNII: K08036XEJV)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYGLYCERIN-10 (UNII: P9060O936A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-225-06	178 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2007

Labeler - Efficient Laboratories Inc (969044932)

Registrant - Efficient Laboratories Inc (969044932)