SPL v3
SPL
SPL Set ID 9b09b660-0758-48dc-84c9-26cdd2aacc03
Route
ORAL
Published
Effective Date 2018-09-26
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
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-05

Description

Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant Nasal Decongestant


Medication Information

Purpose

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal Decongestant

Description

Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg

Uses

temporarily relieves these common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • sore throat
  • headache
  • fever
  • helps loosed phlegm (mucus) ang thin bronchial secretions to drain bronchial tubes



Warnings

Liver warning This product contains

acetaminophen. Severe liver damage

may occur if you take: ■ more than

4,000 mg of acetaminophen in 24 hours

■ with other drugs containing

acetaminophen

■ 3 or more alcoholic drinks daily while

using this product

Allery Alert: Acetaminophen may cause

severe skin reaction. Symptoms may include:

■ skin reddening - blisters ■ rash

If a 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, headache, rash, nausea or vomiting, consult a doctor promptly.

Directions

Age                                                                                  Dose



Adults and children 12 years and older                                20 mL every 4 hours

Children under 12 years of age                                           Do not use



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 pharmacist.
  • if you are taking  a prescription monamine 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 pharmacist before taking this product
  • for children under 12 years of age
Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Product Label

Compare to Mucinex® FAST-MAX™ 

Cold, Flu & Sore Throat active ingredients*

                                    NDC 37808-316-25

H E B®

Maximum Strength

MAX COLD, FLU & SORE THROAT

Acetaminophen /

(Pain Reliver/Fever Reducer)

Dextromethorphan HBr /

(Cough Suppressant)

Guaifensin / (Expectorant)

Phenylephrine HCL /

Nasal Decongestant)

Cold, Flu & Throat



Relief of:

• Fever and Body aches

• Controls Cough

• Thins and Loosens Mucus

• Relieves Nasal and Chest Congestion

Adults

For ages 12 and Over

6 FL OZ (117 mL)              LF-002 Rev.2 02

Peel Corner to Read Complete Drug Facts and Information

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Failure to follow these warnings could result in consequences

100%

GUARANTEE

promise

If you aren't completely pleased

with this product, we’ll be happy to

replace it or refund your money.

You have our word on it.

LB-002 Rev 02

               1208



Lot:

Exp:





Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact the Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information
  • each 20 mL contains: sodium 10 mg

  • dosage cup provided
  • store between 20°-25° C (68°-7°7 F)
  • do not refrigerate
Inactive Ingredients

 Anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

When Using This Product
  • do not use more than directed
Stop Use and Ask A Doctor If
  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
Drug Facts Active Ingredients

Active ingredients (in each 20 mL)



Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

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

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or empysema
  • cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin.

Structured Label Content

Uses

temporarily relieves these common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • sore throat
  • headache
  • fever
  • helps loosed phlegm (mucus) ang thin bronchial secretions to drain bronchial tubes



Purpose

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Nasal Decongestant

Warnings

Liver warning This product contains

acetaminophen. Severe liver damage

may occur if you take: ■ more than

4,000 mg of acetaminophen in 24 hours

■ with other drugs containing

acetaminophen

■ 3 or more alcoholic drinks daily while

using this product

Allery Alert: Acetaminophen may cause

severe skin reaction. Symptoms may include:

■ skin reddening - blisters ■ rash

If a 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, headache, rash, nausea or vomiting, consult a doctor promptly.

Directions

Age                                                                                  Dose



Adults and children 12 years and older                                20 mL every 4 hours

Children under 12 years of age                                           Do not use



Do Not Use (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 pharmacist.
  • if you are taking  a prescription monamine 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 pharmacist before taking this product
  • for children under 12 years of age
Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Product Label

Compare to Mucinex® FAST-MAX™ 

Cold, Flu & Sore Throat active ingredients*

                                    NDC 37808-316-25

H E B®

Maximum Strength

MAX COLD, FLU & SORE THROAT

Acetaminophen /

(Pain Reliver/Fever Reducer)

Dextromethorphan HBr /

(Cough Suppressant)

Guaifensin / (Expectorant)

Phenylephrine HCL /

Nasal Decongestant)

Cold, Flu & Throat



Relief of:

• Fever and Body aches

• Controls Cough

• Thins and Loosens Mucus

• Relieves Nasal and Chest Congestion

Adults

For ages 12 and Over

6 FL OZ (117 mL)              LF-002 Rev.2 02

Peel Corner to Read Complete Drug Facts and Information

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Failure to follow these warnings could result in consequences

100%

GUARANTEE

promise

If you aren't completely pleased

with this product, we’ll be happy to

replace it or refund your money.

You have our word on it.

LB-002 Rev 02

               1208



Lot:

Exp:





Overdose Warning (Overdose warning)

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact the Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • each 20 mL contains: sodium 10 mg

  • dosage cup provided
  • store between 20°-25° C (68°-7°7 F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

 Anhydrous citric acid, edetate disodium, FD and C Blue #1, FD and C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
Drug Facts Active Ingredients (Drug Facts Active ingredients)

Active ingredients (in each 20 mL)



Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

If Pregnant 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.)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right awaay.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or empysema
  • cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin.

Advanced Ingredient Data


Raw Label Data

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