COUGH AND CONGESTION- dextromethorphan hbr, guaifenesin solution

Cough and Congestion by

Drug Labeling and Warnings

Cough and Congestion by is a Otc medication manufactured, distributed, or labeled by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough suppressant
Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  

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 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. 

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition. 

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• do not take more than directed
• do not take more than 6 doses in any 24-hour period
• mL = milliliter
• only use the dose cup provided
• adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
• children under 12 years: do not use

Other information

• each 20 mL contains: sodium 16 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-800-426-9391

Principal Display

♥CVSHealth®

NDC: 51316-500-19

MAXIMUM STRENGTH
COUGH &
CONGESTION

DEXTROMETHORPHAN HBr
Cough Suppressant
GUAIFENESIN
Expectorant
Oral Solution

SYMPTOM RELIEF
Controls cough
Relieves chest
congestion & mucus

For Ages 12 & Over

Compare to the active ingredients
in Robitussin® Maximum Strength
Cough + Chest Congestion DM†

8 FL OZ
(237 mL)

Menthol-Berry Flavor

♥CVSHealth®

You have quality
standards. So do we.
Keep your symptoms in
check with quality products
you can trust.
With our CVS Health® brand,
we perform ongoing tests
and monitor customer
feedback to help us exceed
your expectations.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2024 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-19849

100% money back
guaranteed.
CVS.com/returnpolicy

†This product is not manufactured or distributed by
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC,
owner of the registered trademark Robitussin®
Maximum Strength Cough + Chest Congestion DM.
50844 ORG012303019

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

CVS 44-030

INGREDIENTS AND APPEARANCE

COUGH AND CONGESTION 
dextromethorphan hbr, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-500
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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	red (MAROON)	Score
Shape		Size
Flavor	MENTHOL, BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-500-19	1 in 1 CARTON	04/08/2024
1		237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/08/2024

Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(51316-500) , pack(51316-500)