SPL v10
SPL
SPL Set ID 2ec319a8-92bf-4552-86dd-37cbce18980f
Route
ORAL
Published
Effective Date 2019-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Doxylamine (12.5 mg) Phenylephrine (10 mg)
Inactive Ingredients
Potassium Citrate Myrrh Potassium Sorbate Propylene Glycol Propylparaben Ulmus Rubra Bark Mullein Leaf Sodium Chloride Sucralose Water Prunus Serotina Bark Zinc Sulfate Methylparaben Caulophyllum Thalictroides Root Echinacea, Unspecified Eucalyptus Oil Ginkgo Glycerin Goldenseal Honey Horehound Licorice Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-09-01 Until 2026-11-30

Description

Active ingredients (in each 30 mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine Succinate 12.5 mg Phenylephrine HCl 10 mg


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take

  • more than 6 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophen may cause sever 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 sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminphen, ask a doctor or pharmacist.
  • if you are now 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 prescription drug contains a MAOI, ask a doctor or pharmalacist before taking this product.
  • to make a child sleep

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked draowsiness may occur
  • acoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Indications and Usage

Uses temporarily relieves these common cold/flu symtoms:

  • minor aches and pains
  • headache
  • nasal congestion
  • sore throat
  • runny nose and sneezing
  • cough
  • sinus congestion and pressure
  • helps clear nasal passages
  • relieves cough to help you get to sleep
  • temporarily reduces fever
Dosage and Administration

Directions

  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device. Product color & flavor may vary due to natural honey. 
  • mL = milliliter
  • shake well before use
  • keep dosing cup with product
  • Adults and Children 12 years & over: 30 mL every 4 hours
  • Children under 12 years of age: do not use
Description

Active ingredients (in each 30 mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine Succinate 12.5 mg Phenylephrine HCl 10 mg

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients: blue cohosh root extract, echinacea root extract, eucalyptus oil, flavor, ginkgo bilboa leaf extract, glycerin, goldenseal root extract, honey, horehouns (flower, leaf, stern) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum, potassium citrate, potassium sorbate, propylene glycol, prolylparaben, 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 (9 AM - 5 PM EST) or www.efficientlabs.com

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.  Keep out of reach of children.

Section 55105-1

Purpose

Paint reliever/fever reducer

Cough Suppressant

Antihistamine

Nasal decongestant

Section 55106-9

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine Succinate 12.5 mg

Phenylephrine HCl 10 mg


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves these common cold/flu symtoms:

  • minor aches and pains
  • headache
  • nasal congestion
  • sore throat
  • runny nose and sneezing
  • cough
  • sinus congestion and pressure
  • helps clear nasal passages
  • relieves cough to help you get to sleep
  • temporarily reduces fever
Dosage and Administration (34068-7)

Directions

  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device. Product color & flavor may vary due to natural honey. 
  • mL = milliliter
  • shake well before use
  • keep dosing cup with product
  • Adults and Children 12 years & over: 30 mL every 4 hours
  • Children under 12 years of age: do not use
Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take

  • more than 6 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert: Acetaminophen may cause sever 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 sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminphen, ask a doctor or pharmacist.
  • if you are now 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 prescription drug contains a MAOI, ask a doctor or pharmalacist before taking this product.
  • to make a child sleep

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked draowsiness may occur
  • acoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients: blue cohosh root extract, echinacea root extract, eucalyptus oil, flavor, ginkgo bilboa leaf extract, glycerin, goldenseal root extract, honey, horehouns (flower, leaf, stern) extract, licorice root extract, menthol, methylparaben, mullein leaf extract, myrrh gum, potassium citrate, potassium sorbate, propylene glycol, prolylparaben, 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 (9 AM - 5 PM EST) or www.efficientlabs.com

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.  Keep out of reach of children.

Section 55105-1 (55105-1)

Purpose

Paint reliever/fever reducer

Cough Suppressant

Antihistamine

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine Succinate 12.5 mg

Phenylephrine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

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