Drug Facts

Drug Facts
SPL v17
SPL
SPL Set ID bc10695a-9664-4ce3-82bb-820da06129fa
Route
ORAL
Published
Effective Date 2020-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Brompheniramine Phenylephrine
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2007-10-01 Until 2026-10-31

Description

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


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 you are taking a prescription drug that 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 and nasal congestion as may occur with the common cold
Dosage and 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

Description

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

Section 50565-1

Keep out of reach of children.

In case of 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



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

Section 51727-6

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.

Section 51945-4

Section 53413-1

Questions or Comments?

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

www.efficientlabs.com

Section 53414-9

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



Section 55105-1



Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Section 55106-9



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


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 and nasal congestion as may occur with the common cold
Dosage and Administration (34068-7)

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

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 you are taking a prescription drug that 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 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



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

Section 51727-6 (51727-6)

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.

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

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

Nasal Decongestant

Section 55106-9 (55106-9)



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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)