H E B MAX SEVERE CONGESTION and COUGH
- Manufacturer
- H E B | AptaPharma Inc.
- Effective date
- 2023-12-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:06:02
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg
OTC - PURPOSE SECTION
Purpose
Dextromethorphan HBr ... Cough suppressant
Guaifenesin ....................Expectorant
Phenylephrine HCL ..........Nasal Decongestant
INDICATIONS & USAGE SECTION
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
WARNINGS SECTION
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
OTC - ASK DOCTOR SECTION
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)
OTC - WHEN USING SECTION
When using this product
• do not use more than
directed
OTC - STOP USE SECTION
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.
If pregnant or breast feeding,
ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of
children. In case of overdose,
get medical help or contact a
Poison Control Center right
away.
DOSAGE & ADMINISTRATION SECTION
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
OTHER SAFETY INFORMATION
Other information
- each 20 mL contains: sodium 10 mg
- dosage cup provided
- store between 15-30° C (59-86° F)
- do not refrigerate
INACTIVE INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions? Call weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944
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-MAXTM
Severe Congeslion &Cough
MADE WITH PRIDE & CARE FOR H·E-B®
SAN ANTONIO. TX 78204
res
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 4 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 4 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 4 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37808-317-25 | H E B MAX SEVERE CONGESTION and COUGHMaxium Strength | 177 mL in 1 BOTTLE | LIQUID | 177 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 37808-317 | H E B MAX SEVERE CONGESTION AND COUGH MAXIUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [H E B] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231230_d2b016ee-5329-45bf-9d71-d626204169cf.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| PROPYL GALLATE | INACTIVE INGREDIENT | 8D4SNN7V92 | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- H E B MAX SEVERE CONGESTION and COUGH Maxium Strength
- DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 37808-317 | 37808-317-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYL GALLATE | 8D4SNN7V92 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SUSPENSION / ORAL | 400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CONCENTRATE / ORAL | 0.04 mg/1ml | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM, SOLUBLE / ORAL | 33 mg | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | TABLET / ORAL | 7 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SUSPENSION / ORAL | 160 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SOLUTION / ORAL | 98 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE / ORAL | 5.4 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE / ORAL | 28 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / ORAL | 3900 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | TABLET / ORAL | 7 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE / ORAL | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM, SOLUBLE / ORAL | 7 mg | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EFFERVESCENT / ORAL | 840 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET / ORAL | 30 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SUSPENSION / ORAL | 160 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, FILM COATED / ORAL | 1 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, FOR SUSPENSION / ORAL | 65 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION, EXTENDED RELEASE / ORAL | 24 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION, EXTENDED RELEASE / ORAL | 16 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SYRUP / ORAL | 268 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | PASTE / ORAL | 26 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / ORAL | 15 mg | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | CAPSULE / ORAL | 7 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| PROPYL GALLATE | PROPYL GALLATE | 8D4SNN7V92 | TABLET, FILM COATED / ORAL | 0.04 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER / ORAL | 275 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SOLUTION / ORAL | 414 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE, FOR SUSPENSION / ORAL | 23 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| H E B MAX SEVERE CONGESTION and COUGH Maxium Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | d2b016ee-5329-45bf-9d71-d626204169cf | 2023-12-29 | Warnings | 37808-317-25 37808-317 37808031725 9f2c6806-1156-4c91-8581-68b7fcf039ec d2b016ee-5329-45bf-9d71-d626204169cf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
