Severe Cough and Congestion Maximum Strength
- Manufacturer
- AptaPharma Inc.
- Effective date
- 2019-12-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:52:51
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)
Dexlromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
OTC - PURPOSE SECTION
Purpose
Dexlromethorphan 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 symptoms 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
oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or
emotional conditions, or Parkinson's disease), or for two 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 ● diabetes ● high blood pressure ● 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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
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
Adults & children 12 yeas and older | 20 mL every 4 hours |
| Children under 12 yeas of age | Do not use |
OTHER SAFETY INFORMATION
Other information
● each 20 mL contains: sodium 6mg
● dosage cup provided
● store between 15-30°C (59-86°F)
● do not refrigerate
INACTIVE INGREDIENT SECTION
Inactive ingredients
Anhydrous crtric acid, flavors, purified water, sodium benzoate, sucrose
OTC - QUESTIONS SECTION
Ouestions? CaIl weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Principal Display Panel
CVS
HealthTM
Compare to the active ingredients
in Mucinex® FAST-MAX®
Severe Congestion & Cough*
MAXIMUM STRENGTH
Adult
Severe Cough
& Congestion
Free of alcohol, dyes &
artificial sweeteners
DEXTROMETHORPHAN HBr
Cough suppressant
GUAIFENESIN
Expectorant
PHENYLEPHRINE HCl
Nasal decongestant
Multi-Symptom:
• Relieves nasal &
chest congestion
• Soothes Cough
• Thins & loosens
mucus
For Ages
12 & Over
8 FL OZ (237 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences
DO NOT REFRIGERATE. STORE AT ROOM TEMPERATURE.
*This product is not manufactured or distributed by Reckitt
Benckiser Inc., owner of the registered trademarks Mucinex®
and FAST-MAX®.
Lot:
Exp:
LR-111 REV 01 #339090
0 50428 61767 0
DRUG FACTS →
CONTINUED
ON BACK
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-34690
√CVS Quality
Money Back Guarantee
Product Package
Adult Severe Cough & Congestion by CVS Pharmacy, Inc.
res
Products#
Every source-derived product name is available through these pages.
- Severe Cough and Congestion Maximum Strength
- DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCl
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- WATER
- SODIUM BENZOATE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76281-312 | 76281-312-26 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCROSE | C151H8M554 | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 2506f880-8f91-4497-bb73-b1cc8942fd93 | 87b15122-aa6f-4964-9b32-79a501fe7d19 | 2022-12-16 | Warnings | 87b15122-aa6f-4964-9b32-79a501fe7d19 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
