DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

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 2012-09-14

Medication Information

Warnings and Precautions

Warnings

Do not use • if you are now

taking a prescription monoamine

oxiclase 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

Indications and Usage

Uses

• helps loosen phlegm (mucus)

and thin bronchial secretions to

drain bronchial tubes

• temporarily relieves these

symploms occurring with a cold:

    • cough due to minor throat and

      bronchial irritation

    • nasal congestion

Dosage and Administration

Directions

• take only as recommended

• use dosage cup

• mL = milliliter

• do not take more than 6

doses in any 24-hour period

Age Dose

Adults & 20 ml every 4

children 12 hours

years and

older

Children Do not use

under 12

years of age

Description

Drug Facts

Section 42229-5

Drug Facts

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 50566-9

Stop use and ask a doctor if

• nervousness, dizziness or

sleeplessness occur

• symptoms do not get better

within 7 days or are

accompanied by a fever

• cough comes back, or occurs

with fever, rash or persistent

headache. These could be

signs of a serious condition.

Section 50567-7

When using this product

• do not use more than

directed

Section 50569-3

Ask a doctor before use if

you have

• heart disease

• thyroid disease

• high blood pressure

• diabetes

• trouble urinating due to an

enlarged prostate gland

• cough that lasts or is chronic

such as occurs with smoking,

asthma, chronic bronchitis or

emphysema.

• cough that occurs with too

much phlegm (mucus)

Section 51727-6

Inactive ingredients

anhydrous cilric acid, edetate

disodium, FD&C Blue #1, FD&C Red

#40. flavors. glycerin, propylene

glycol, propyl gallate, purified water,

sodium benzoate, sorbitol, sucralose,

Xanthan gum

Section 53413-1

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Section 55105-1

Purpose

Dextromethorphan HBr ... Cough suppressant

Guaifenesin ....................Expectorant

Phenylephrine HCL ..........Nasal Decongestant

Section 55106-9

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

Section 60561-8

Other information

each 20 mL contains: sodium 10 mg
dosage cup provided
store between 15-30° C (59-86° F)
do not refrigerate

Product Label

Compare to Mucinex^® FAST-MAX™

Severe Congestion and Cough active ingredients*

NDC 37808-317-25

H-E-B_®

Maximum Strength

Max Severe

Congestion &

Cough

Dextromethorphan HBr /

Cough Suppressant

Guaifenesin / Expectorant

Phenylephrine HCI /

Nasal Decongestant

Congestion & Cough

Relief of:

• Cough

• Thins & Loosens Mucus

• Nasal & Chest Congestion

Adults

For Ages 12 & Over

6 FL OZ (177mL)

LF 001 Rev.01

MADE WITH PRIDE AND CARE FOR H-E-B^®

SAN ANTONIO, TEXAS, 782044

Peel Corner to Read Complete

Drug Facts and Information →

DO NOT USE IF PRINTED SEAL

UNDER CAP IS TORN OR MISSING

H-E-B_®

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·001 Rev.01

1208

8581-1711

0 41220 38704 5

Lot:

Exp:

*This product is not manufactured or

distributed by Reckill Benckiser Inc..

distributor of Mucinex^® FAST-MAX^TM

Severe Congeslion &Cough

MADE WITH PRIDE & CARE FOR H·E-B^®

SAN ANTONIO. TX 78204

res

If Pregnant Or Breast Feeding,

ask a health professional before use.

Structured Label Content

Indications and Usage (34067-9)

Uses

• helps loosen phlegm (mucus)

and thin bronchial secretions to

drain bronchial tubes

• temporarily relieves these

symploms occurring with a cold:

    • cough due to minor throat and

      bronchial irritation

    • nasal congestion

Dosage and Administration (34068-7)

Directions

• take only as recommended

• use dosage cup

• mL = milliliter

• do not take more than 6

doses in any 24-hour period

Age Dose

Adults & 20 ml every 4

children 12 hours

years and

older

Children Do not use

under 12

years of age

Warnings and Precautions (34071-1)

Warnings

Do not use • if you are now

taking a prescription monoamine

oxiclase 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

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

Stop use and ask a doctor if

• nervousness, dizziness or

sleeplessness occur

• symptoms do not get better

within 7 days or are

accompanied by a fever

• cough comes back, or occurs

with fever, rash or persistent

headache. These could be

signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

• do not use more than

directed

Section 50569-3 (50569-3)

Ask a doctor before use if

you have

• heart disease

• thyroid disease

• high blood pressure

• diabetes

• trouble urinating due to an

enlarged prostate gland

• cough that lasts or is chronic

such as occurs with smoking,

asthma, chronic bronchitis or

emphysema.

• cough that occurs with too

much phlegm (mucus)

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous cilric acid, edetate

disodium, FD&C Blue #1, FD&C Red

#40. flavors. glycerin, propylene

glycol, propyl gallate, purified water,

sodium benzoate, sorbitol, sucralose,

Xanthan gum

Section 53413-1 (53413-1)

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Section 55105-1 (55105-1)

Purpose

Dextromethorphan HBr ... Cough suppressant

Guaifenesin ....................Expectorant

Phenylephrine HCL ..........Nasal Decongestant

Section 55106-9 (55106-9)

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

Section 60561-8 (60561-8)

Other information

each 20 mL contains: sodium 10 mg
dosage cup provided
store between 15-30° C (59-86° F)
do not refrigerate

Product Label

Compare to Mucinex^® FAST-MAX™

Severe Congestion and Cough active ingredients*

NDC 37808-317-25

H-E-B_®

Maximum Strength

Max Severe

Congestion &

Cough

Dextromethorphan HBr /

Cough Suppressant

Guaifenesin / Expectorant

Phenylephrine HCI /

Nasal Decongestant

Congestion & Cough

Relief of:

• Cough

• Thins & Loosens Mucus

• Nasal & Chest Congestion

Adults

For Ages 12 & Over

6 FL OZ (177mL)

LF 001 Rev.01

MADE WITH PRIDE AND CARE FOR H-E-B^®

SAN ANTONIO, TEXAS, 782044

Peel Corner to Read Complete

Drug Facts and Information →

DO NOT USE IF PRINTED SEAL

UNDER CAP IS TORN OR MISSING

H-E-B_®

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·001 Rev.01

1208

8581-1711

0 41220 38704 5

Lot:

Exp:

*This product is not manufactured or

distributed by Reckill Benckiser Inc..

distributor of Mucinex^® FAST-MAX^TM

Severe Congeslion &Cough

MADE WITH PRIDE & CARE FOR H·E-B^®

SAN ANTONIO. TX 78204

res

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symploms occurring with a cold: • cough due to minor throat and bronchial irritation • nasal congestion", "34068-7": "Directions • take only as recommended • use dosage cup • mL = milliliter • do not take more than 6 doses in any 24-hour period Age Dose Adults & 20 ml every 4 children 12 hours years and older Children Do not use under 12 years of age", "34071-1": "Warnings Do not use • if you are now taking a prescription monoamine oxiclase 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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • symptoms do not get better within 7 days or are accompanied by a fever • cough comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.", "50567-7": "When using this product • do not use more than directed", "50569-3": "Ask a doctor before use if you have • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema. • cough that occurs with too much phlegm (mucus)", "51727-6": "Inactive ingredients anhydrous cilric acid, edetate disodium, FD&C Blue #1, FD&C Red #40. flavors. glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum", "53413-1": "Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944", "55105-1": "Purpose Dextromethorphan HBr ... Cough suppressant Guaifenesin ....................Expectorant Phenylephrine HCL ..........Nasal Decongestant", "55106-9": "Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg", "60561-8": "Other information each 20 mL contains: sodium 10 mg dosage cup provided store between 15-30° C (59-86° F) do not refrigerate", "Product Label": "Compare to Mucinex ® FAST-MAX™ Severe Congestion and Cough active ingredients* NDC 37808-317-25 H-E-B ® Maximum Strength Max Severe Congestion & Cough Dextromethorphan HBr / Cough Suppressant Guaifenesin / Expectorant Phenylephrine HCI / Nasal Decongestant Congestion & Cough Relief of: • Cough • Thins & Loosens Mucus • Nasal & Chest Congestion Adults For Ages 12 & Over 6 FL OZ (177mL) LF 001 Rev.01 MADE WITH PRIDE AND CARE FOR H-E-B ® SAN ANTONIO, TEXAS, 782044 Peel Corner to Read Complete Drug Facts and Information → DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING H-E-B ® 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·001 Rev.01 1208 8581-1711 0 41220 38704 5 Lot: Exp: *This product is not manufactured or distributed by Reckill Benckiser Inc.. distributor of Mucinex ® FAST-MAX TM Severe Congeslion &Cough MADE WITH PRIDE & CARE FOR H·E-B ® SAN ANTONIO. TX 78204 res", "If pregnant or breast feeding,": "ask a health professional before use."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information