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#

ProductSevere Cough and Congestion Maximum Strength
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

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

Age                                                              Dose

 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

PACKAGE LABEL.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

312-26 Label312-26 Label

                             Adult Severe Cough & Congestion by CVS Pharmacy, Inc.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-31276281-312-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2506f880-8f91-4497-bb73-b1cc8942fd9387b15122-aa6f-4964-9b32-79a501fe7d192022-12-16WarningsExact identifier
spl set id: 87b15122-aa6f-4964-9b32-79a501fe7d19

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.