COUGH- dextromethorphan hbr solution 
HyVee Inc

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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Hy-Vee, Inc. Cough Drug Facts

Active ingredient (in each 15 mL)

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant

Use

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

COMPARE TO the Active Ingredient of Vicks® DayQuil® Cough

Non-Drowsy

Cough

Dextromethorphan HBr – Cough Suppressant

Daytime

All Day Cough Relief Up to 8 Hours

Cough

Alcohol Free

Antihistamine Free

Citrus Blend Flavor

12 FL OZ (355 mL)

HyVee Health Cough image
COUGH 
dextromethorphan hbr solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-500
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 GLYCOLS (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:42507-500-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 02/12/2014
Labeler - HyVee Inc (006925671)

Revised: 3/2016
Document Id: 6892fddb-b8f7-4257-8345-461c171058a9
Set id: 901cfa98-ff70-4779-bdeb-e55372d6200f
Version: 2
Effective Time: 20160331
 
HyVee Inc