Walgreen Co. Cough Drug Facts

Cough by

Drug Labeling and Warnings

Cough by is a Otc medication manufactured, distributed, or labeled by Walgreen Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COUGH- dextromethorphan hbr solution 
Walgreen Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Walgreen Co. Cough Drug Facts

Active ingredient (in each 15 mL)

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant

Uses

temporarily relieves cough due to minor throat and bronchial irritation associated with a cold

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, or emphysema

Stop use and ask a doctor if

cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

Directions

• take only as directed
• use dose cup
• do not exceed 4 doses per 24 hours

• adults and children 12 years and over:

  30 mL every 6-8 hours

• children 6 to under 12 years:

  15 mL every 6-8 hours

• children 4 to under 6 years:

  ask a doctor

• children under 4 years:

  do not use

Other information

• each 15 mL contains: sodium 13 mg
• store at 20-25°C (68-77°F)
• does not meet USP requirements for light resistant packaging

Inactive ingredients

anhydrous citric acid, D&C yellow #10, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

1-800-719-9260

Principal Display Panel

DAYTIME - NON-DROWSY

Cough

Dextromethorphan HBr / Cough

Cough suppressant

Antihistamine free

Alcohol free

DAYTIME

8 LASTS UP TO 8 HOURS

CITRUS BLEND FLAVOR

Compare to Vicks® DayQuil® Cough active ingredient

12 FL OZ (355 mL)

COUGH 
dextromethorphan hbr solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0500
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	ORANGE (light)	Score
Shape		Size
Flavor	CITRUS (blend)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0500-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2014	08/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/20/2014	08/26/2019

Labeler - Walgreen Company (008965063)

Revised: 12/2019

Document Id: 887920ca-fde1-4961-a45d-8c4de49e7665

34390-5

Set id: 428d6a02-ff38-4b3b-b301-dca16755064e

Version: 3

Effective Time: 20191216