ROMPE PECHO SF FLU SF FLU- brompheniramine maleate, dextromethorphan hbr liquid

Rompe Pecho SF Flu by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:(in each teaspoonful 5 ml.) Purpose

Brompheniramine Maleate 4mg ................................................ Antihistamine

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

PURPOSE

Purpose

Antihistamine

Cough Suppressant

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 your prescription drug 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

Stop use and ask 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 sign of a serious condition.
• nervousness, dizziness, or sleeplessness occurs

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 accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Do not exceed more than 6 doses in any 24-hour period
• Shake well before use
• measure only with dosing cup provided
• keep dosing cup with product
• mL=miliiter TSP=teaspoonful
• this adult product is not intended for use in children under 12 years of age

• Age:
  • Dose
• adults and children 12 years of age and over:
  • 5 mL (1 teaspoonfuls) every 4 hours
• children under 6 years of age:
  • do not use

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 from the common cold

INACTIVE INGREDIENT

Inactive Ingredients:Blue Cohosh root extract, citric acid, Echinacea root extract, Eucalyptus Oil, Flavor, Ginkgo Biloba leaf extract, glycerin, Golden Seal root extract, Honey, Horehound (flower, leaf, stem) extract, 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 and Zinc Sulfate.

QUESTIONS

Questions or Comments?

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

www.efficientlabs.com

Distributed by

Efficient Laboratories, Inc., Miami, Fl 33166

Made in U.S.A.

Ask a doctor or pharmacist before use if you are:

taking tranquilizers or sedatives

When using this product

When using this product may cause marked drowsiness avoid alcoholic drinks Alcohol, sedatives, and tranquilizers may increase drowsiness effect use caution when driving a motor vehicle or operating machinery excitability may occur, especially in childrens.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROMPE PECHO SF FLU  SF FLU
brompheniramine maleate, dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58593-002
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	4 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)
GLYCERIN (UNII: PDC6A3C0OX)
ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
GOLDENSEAL (UNII: ZW3Z11D0JV)
HONEY (UNII: Y9H1V576FH)
HOREHOUND (UNII: K08036XEJV)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
LICORICE (UNII: 61ZBX54883)
MULLEIN LEAF (UNII: 9936O846LI)
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)
MYRRH (UNII: JC71GJ1F3L)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58593-002-06	178 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/01/2023

Labeler - Efficient Laboratories Inc (969044932)

Registrant - Efficient Laboratories Inc (969044932)