GOOD SENSE NIGHTTIME COUGH - dextromethorphan hydrobromide and doxylamine succinate liquid
L Perrigo 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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Active ingredients (in each 15 ml tablespoon)

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Cough suppressant

Antihistamine

Uses

temporarily relieves cold symptoms:

•: cough
•: runny nose and sneezing

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.
•: to make a child sleepy

Ask a doctor before use if you have

•: glaucoma
•: a breathing problem such as emphysema or chronic bronchitis
•: cough that occurs with too much phlegm (mucus)
•: trouble urinating due to an enlarged prostate gland
•: persistent or chronic cough as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

•: do not use more than directed
•: excitability may occur, especially in children
•: may cause marked drowsiness
•: avoid alcoholic drinks
•: be careful when driving a motor vehicle or operating machinery
•: alcohol, sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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. (1-800-222-1222)

Directions

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

adults and children 12 years and over	30 ml (2 TBSP) every 6 hours
children 4 to under 12 years	ask a doctor
children under 4 years	do not use

•: when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information

•: each tablespoon contains: sodium 16 mg
•: store at 20°-25°C (68°-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, 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

All Night Cough Relief

NightTime Cough

Dextromethorphan HBr

Doxylamine Succinate

Cough

Sneezing

Runny Nose

Cherry Flavor

Cough Suppressant, Antihistamine

Compare to active ingredients of Vicks® NyQuil® Cough

ALCOHOL 10%

GOOD SENSE NIGHTTIME COUGH
dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-0668
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE)	DOXYLAMINE SUCCINATE	6.25 mg in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOLS
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM DIHYDRATE
SODIUM CITRATE

Product Characteristics
Color	RED (Dark Red)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0113-0668-30	177 mL in 1 BOTTLE	None
2	NDC:0113-0668-34	237 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/03/2002

Labeler - L Perrigo Company (006013346)

Revised: 10/2012 L Perrigo Company