DG HEALTH COUGH NITE TIME - dextromethorphan hydrobromide and doxylamine succinate liquid 
Dolgencorp, LLC

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Dolgencorp, LLC Nite Time Cough Drug Facts

Active ingredient (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
• marked drowsiness may occur
• 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 for 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.

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 TBSP contains: sodium 15 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?

1-888-309-9030

Principal Display Panel

Nite Time

Cough

All Night Cough Relief

Antihistamine: Doxylamine Succinate

Cough Suppressant: Dextromethorphan HBr

Compare to active ingredients o NyQuil® Cough

See Labeling Changes

Cherry Flavor

Alcohol 10%

DG HEALTH COUGH  NITE TIME dextromethorphan hydrobromide, doxylamine succinate   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 55910-668 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 GLYCOL   PROPYLENE GLYCOL   WATER   SACCHARIN SODIUM   SODIUM CITRATE

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

Packaging # NDC Package Description Multilevel Packaging 1 55910-668-38 296 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/21/2009

Labeler - Dolgencorp, LLC (068331990)

Revised: 11/2009Dolgencorp, LLC