SEVERE COUGH AND CONGESTION MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Severe Cough and Congestion Maximum Strength by

Drug Labeling and Warnings

Severe Cough and Congestion Maximum Strength by is a Otc medication manufactured, distributed, or labeled by AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)
Dexlromethorphan HBr                20 mg
Guaifenesin                            400 mg
Phenylephrine HCl                     10 mg

PURPOSE

Purpose
Dexlromethorphan HBr ............... Cough suppressant
Guaifenesin  ............................. Expectorant
Phenylephrine HCl ..................... Nasal Decongestant

INDICATIONS & USAGE

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

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

ASK DOCTOR

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)

WHEN USING

When using this product ● do not use more than directed

STOP USE

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.

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

DOSAGE & ADMINISTRATION

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

Inactive ingredients
Anhydrous crtric acid, flavors, purified water, sodium benzoate, sucrose

QUESTIONS

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

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  Money Back Guarantee

Product Package

                             Adult Severe Cough & Congestion by CVS Pharmacy, Inc.

res

INGREDIENTS AND APPEARANCE

SEVERE COUGH AND CONGESTION MAXIMUM STRENGTH 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-312
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-312-26	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-312)