SPL v10
SPL
SPL Set ID 938e4e47-d2d9-4b0d-bf88-e9f41b501945
Route
ORAL
Published
Effective Date 2020-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Water Prunus Serotina Bark Zinc Sulfate Caulophyllum Thalictroides Root Citric Acid Monohydrate Echinacea, Unspecified Eucalyptus Oil Ginkgo Glycerin Goldenseal Honey Horehound Licorice Menthol Methylparaben Mullein Leaf Myrrh Potassium Citrate Potassium Sorbate Propylene Glycol Propylparaben Ulmus Rubra Bark Sodium Chloride Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-01-01

Description

Active ingredients                                            Purposes (in each 20mL) Acetaminophen 650 mg..................................Pain reliever/feverreducer Dextromethorphan Hbr 20 mg............................Cough suppressant Guaifenesin 400 mg...........................................Expectorant Phenylephtine HCl 10 mg...................................Nasal decongestant


Medication Information

Warnings and Precautions

Warning

Liver warning: this product contains acetaminophen.

Severe liver damage may occur if:

  • you take more than 6 doses in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • 3 or more alcoholic drinkss every day while using this product.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash.

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by, fever, headahce, rash, nausea or vomiting, consult a doctor promtly.

Indications and Usage

Uses

  • temprarily relieves these common cold and flu symptoms:
  • nasal congestion
  • sinus congestion and pressure 
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage and Administration

Directions

  • do not take more than 6 doses in any 24 hours
  • shake well before use
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult strength product is not intended for use in children under 12 years of age
age dose
adults and children 12 years of age and over 20 mL every 4 hours
children under 12 years of age do not use
Description

Active ingredients                                            Purposes (in each 20mL) Acetaminophen 650 mg..................................Pain reliever/feverreducer Dextromethorphan Hbr 20 mg............................Cough suppressant Guaifenesin 400 mg...........................................Expectorant Phenylephtine HCl 10 mg...................................Nasal decongestant

Section 34088-5

Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Section 43683-2

Recommendations should be added in the Directions section, such as:

• do not take more 6 doses in any 24 hours

• measure only with dosing cup provided

• keep dosing cup with product

• mL= milliliter

• this strength product is not intended for use in children under 12 years of age

Typographical adjustments were made, and clarity was provided on the dosage by age through a table:

age dose
adults and children 12 years of age and over 20 mL every 4 hours
children under 12 years of age do not use

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition
  • nervousness, dizziness or sleeplessness occurs
  • pain and nasal congestion gets worse or last more than 5 days (children) or 7 days (adults)
  • fever gets worse or last more than 3 days
  • redness or swelling is present or new symptoms occur.
Section 50567-7

When using this product do not use more than directed

Section 50568-5

Ask a doctor before use if you have

  • heart disease
  • liver disease
  • 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, chronic bronchitis or emphysema.
  • a cough that is followed by excessive phlegm (mucus)

Ask a docotor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking tranquilizers or sedatives
Section 50570-1

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription).
  • if you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
  • if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • 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 a doctor or pharmamcist before taking this product.
Section 51727-6

Inactive ingreadients:

Blue cohosh root extract, citirc acid, echinacea root extract, eucalptus oil, ginko biloba leaf extract, glycerin, goldenseal root extract, honey, horehound (flower, leaf, stem) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum, potassium citrate, potassium sorbate, propylene glycol, propylparaben, slippery elm bark extract, sodium chloride, suralose, water, wild cherry bark extract and zinc sulfate.

Section 51945-4

Section 53413-1

Questions or comments?

(305) 805-3456 Monday to Friday from 9 am to 5 pm EST or www.efficientlabs.com

Section 53414-9

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

Section 55105-1
  • Pain reliever/fever reducer
  • Cough suppressant
  • Expectorant
  • Nasal decongestant
Section 55106-9

Active ingredients                                            Purposes

(in each 20mL)

Acetaminophen 650 mg..................................Pain reliever/feverreducer

Dextromethorphan Hbr 20 mg............................Cough suppressant

Guaifenesin 400 mg...........................................Expectorant

Phenylephtine HCl 10 mg...................................Nasal decongestant


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temprarily relieves these common cold and flu symptoms:
  • nasal congestion
  • sinus congestion and pressure 
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 doses in any 24 hours
  • shake well before use
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult strength product is not intended for use in children under 12 years of age
age dose
adults and children 12 years of age and over 20 mL every 4 hours
children under 12 years of age do not use
Warnings and Precautions (34071-1)

Warning

Liver warning: this product contains acetaminophen.

Severe liver damage may occur if:

  • you take more than 6 doses in 24 hours, which is the maximum daily amount for this product
  • taken with other drugs containing acetaminophen
  • 3 or more alcoholic drinkss every day while using this product.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash.

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by, fever, headahce, rash, nausea or vomiting, consult a doctor promtly.

Section 34088-5 (34088-5)

Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Section 43683-2 (43683-2)

Recommendations should be added in the Directions section, such as:

• do not take more 6 doses in any 24 hours

• measure only with dosing cup provided

• keep dosing cup with product

• mL= milliliter

• this strength product is not intended for use in children under 12 years of age

Typographical adjustments were made, and clarity was provided on the dosage by age through a table:

age dose
adults and children 12 years of age and over 20 mL every 4 hours
children under 12 years of age do not use

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition
  • nervousness, dizziness or sleeplessness occurs
  • pain and nasal congestion gets worse or last more than 5 days (children) or 7 days (adults)
  • fever gets worse or last more than 3 days
  • redness or swelling is present or new symptoms occur.
Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50568-5 (50568-5)

Ask a doctor before use if you have

  • heart disease
  • liver disease
  • 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, chronic bronchitis or emphysema.
  • a cough that is followed by excessive phlegm (mucus)

Ask a docotor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking tranquilizers or sedatives
Section 50570-1 (50570-1)

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription).
  • if you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
  • if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • 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 a doctor or pharmamcist before taking this product.
Section 51727-6 (51727-6)

Inactive ingreadients:

Blue cohosh root extract, citirc acid, echinacea root extract, eucalptus oil, ginko biloba leaf extract, glycerin, goldenseal root extract, honey, horehound (flower, leaf, stem) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum, potassium citrate, potassium sorbate, propylene glycol, propylparaben, slippery elm bark extract, sodium chloride, suralose, 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 to Friday from 9 am to 5 pm EST or www.efficientlabs.com

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
  • Pain reliever/fever reducer
  • Cough suppressant
  • Expectorant
  • Nasal decongestant
Section 55106-9 (55106-9)

Active ingredients                                            Purposes

(in each 20mL)

Acetaminophen 650 mg..................................Pain reliever/feverreducer

Dextromethorphan Hbr 20 mg............................Cough suppressant

Guaifenesin 400 mg...........................................Expectorant

Phenylephtine HCl 10 mg...................................Nasal decongestant


Advanced Ingredient Data


Raw Label Data

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