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Rompe Pecho SF FLU

Medically reviewed on August 10, 2017

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, BROMPHENIRAMINE MALEATE 10mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 5mL
Labeler: Efficient Laboratories Inc
NDC Code: 58593-225

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 (in each 5 mls tsp.)                          Purpose

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

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

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


Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

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

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.


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

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


Keep out of reach of children.

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

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 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 or Comments?

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

www.efficientlabs.com

ROMPE PECHO  SF FLU
dextromethorphan, brompheniramine maleate, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-225
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE 
CAULOPHYLLUM THALICTROIDES ROOT 
ECHINACEA, UNSPECIFIED 
EUCALYPTUS GLOBULUS LEAF 
GINKGO 
GOLDENSEAL 
HONEY 
GLYCYRRHIZA GLABRA 
MENTHOL 
METHYLPARABEN 
VERBASCUM DENSIFLORUM LEAF 
MYRRH 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
ULMUS RUBRA BARK 
SODIUM CHLORIDE 
PRUNUS SEROTINA BARK 
ZINC SULFATE 
HOREHOUND 
CITRIC ACID MONOHYDRATE 
POLYGLYCERIN-10 
Packaging
#Item CodePackage Description
1NDC:58593-225-06178 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2007
Labeler - Efficient Laboratories Inc (969044932)
Registrant - Efficient Laboratories Inc (969044932)

 
Efficient Laboratories 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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