FDA Label for Nitetime Cough Daytime Cough

View Indications, Usage & Precautions

ACTIVE INGREDIENTS (IN EACH 30 ML DOSE CUP) - NIGHTTIME COUGH
ACTIVE INGREDIENT (IN EACH 15 ML TABLESPOON) - DAYTIME COUGH
PURPOSE - NIGHTTIME COUGH
PURPOSE - DAYTIME COUGH
USES – NIGHTTIME COUGH
USES – DAYTIME COUGH
DO NOT USE – NIGHTTIME COUGH
DO NOT USE – DAYTIME COUGH
ASK A DOCTOR BEFORE USE IF YOU HAVE – NIGHTTIME COUGH
ASK A DOCTOR BEFORE USE IF YOU HAVE – DAYTIME COUGH
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE – NIGHTTIME COUGH
WHEN USING THIS PRODUCT – NIGHTTIME COUGH
WHEN USING THIS PRODUCT – DAYTIME COUGH
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS – NIGHTTIME COUGH
DIRECTIONS – DAYTIME COUGH
OTHER INFORMATION – NIGHTTIME COUGH
OTHER INFORMATION – DAYTIME COUGH
INACTIVE INGREDIENTS – NIGHTTIME COUGH
INACTIVE INGREDIENTS – DAYTIME COUGH
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL – NIGHTTIME COUGH
PRINCIPAL DISPLAY PANEL – DAYTIME COUGH

Nitetime Cough Daytime Cough Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each 30 Ml Dose Cup) - Nighttime Cough

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Active Ingredient (In Each 15 Ml Tablespoon) - Daytime Cough

Dextromethorphan HBr 15 mg

Purpose - Nighttime Cough

Cough suppressant

Antihistamine

Purpose - Daytime Cough

Cough suppressant

Uses – Nighttime Cough

temporarily relieves cold symptoms

•cough
•runny nose and sneezing

Uses – Daytime Cough

temporarily relieves cough due to minor throat and bronchial irritation

Do Not Use – Nighttime Cough

•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

Do Not Use – Daytime Cough

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 – Nighttime Cough

•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 Before Use If You Have – Daytime Cough

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

Ask A Doctor Or Pharmacist Before Use If You Are – Nighttime Cough

taking sedatives or tranquilizers

When Using This Product – Nighttime Cough

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

When Using This Product – Daytime Cough

do not use more than directed

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 – Nighttime Cough

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

adults and children 12 years and over	30 mL (2 TBSP) every 6 hrs
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

Directions – Daytime Cough

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

adults and children 12 years & over	30 mL (2 TBSP) every 6 to 8 hrs
children 6 to under 12 years	15 mL (1 TBSP) every 6 to 8 hrs
children 4 to under 6 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 – Nighttime Cough

•each 30 mL dose cup contains: sodium 32 mg
•store at 20°-25°C (68°-77°)

Other Information – Daytime Cough

•each tablespoon contains: sodium 13 mg
•store at 20°-25°C (68°-77°)

Inactive Ingredients – Nighttime Cough

alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Inactive Ingredients – Daytime Cough

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 – Nighttime Cough

VALUE 2 PACK

Compare to Vicks® NyQuil® Cough active ingredients

Cherry Flavor

NiteTime Cough

Cough Suppressant, Antihistamine

All Night Cough Relief

Dextromethorphan HBr – cough

Doxylamine Succinate – sneezing, runny nose

ALCOHOL 10%

12 FL OZ (355 mL)

Principal Display Panel – Daytime Cough