Rompe Pecho Sf Flu

Rompe Pecho Sf Flu
SPL v6
SPL
SPL Set ID 06eac696-e8f6-ac50-e063-6394a90a2ed6
Route
ORAL
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Brompheniramine (4 mg)
Inactive Ingredients
Anhydrous Citric Acid Potassium Citrate Anhydrous Eucalyptus Oil Caulophyllum Thalictroides Root Glycerin Echinacea Angustifolia Root Ginkgo Biloba Leaf Oil Goldenseal Honey Horehound Menthol Methylparaben Licorice Mullein Leaf Potassium Sorbate Propylene Glycol Propylparaben Water Ulmus Rubra Bark Sodium Chloride Prunus Serotina Bark Zinc Sulfate Myrrh Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

Active Ingredients: (in each teaspoonful 5 ml.) Purpose Brompheniramine Maleate 4mg ................................................ Antihistamine Dextromethorphan HBr 10 mg .................................................... Cough Suppressant


Medication Information

Warnings and Precautions

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.

Indications and 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

Dosage and 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

Description

Active Ingredients: (in each teaspoonful 5 ml.) Purpose Brompheniramine Maleate 4mg ................................................ Antihistamine Dextromethorphan HBr 10 mg .................................................... Cough Suppressant

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1





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
Section 51727-6

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.

Section 51945-4

Section 53413-1

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.

Section 53414-9

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



Section 55105-1

Purpose

Antihistamine

Cough Suppressant

Section 55106-9

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

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

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

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.



Ask A Doctor Or Pharmacist Before Use If You Are:

taking tranquilizers or sedatives


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)





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
Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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.

Section 53414-9 (53414-9)

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



Section 55105-1 (55105-1)

Purpose

Antihistamine

Cough Suppressant

Section 55106-9 (55106-9)

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

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

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

When Using This Product (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.



Ask A Doctor Or Pharmacist Before Use If You Are: (Ask a doctor or pharmacist before use if you are:)

taking tranquilizers or sedatives


Advanced Ingredient Data


Raw Label Data

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