DAYTIME NIGHTTIME MULTI SYMPTOM COLD FLU RELIEF - acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
CVS Pharmacy

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CVS Pharmacy, Inc. Daytime and Nighttime Cold/Flu Relief Combo Pack Drug Facts

Active ingredient for Nighttime (in each 15 mL tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredient for Daytime (in each 15 mL tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

nasal congestion (Daytime only)
sore throat
cough due to minor throat and bronchial irritation
headache
minor aches and pains
fever
runny nose and sneezing (Nighttime only)

Warnings

Liver warning: These products contain acetaminophen. Severe liver damage may occur if:

adult takes more than 4 doses in 24 hours (Nighttime) or more than 6 doses in 24 hours (Daytime), which is the maximum daily amount
child takes more than 5 doses in 24 hours (Daytime)
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using these products

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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

high blood pressure (Daytime only)
heart disease (Daytime only)
diabetes (Daytime only)
thyroid disease (Daytime only)
trouble urinating due to an enlarged prostate gland
liver disease
cough that occurs with too much phlegm (mucus)
persistent or chronic cough as occurs with smoking, asthma or emphysema
a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
glaucoma (Nighttime only)
a sodium-restricted diet (Nighttime only)

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using these products

do not use more than directed

In addition, when using Nighttime:

avoid alcoholic drinks
marked drowsiness may occur
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

you get nervous, dizzy or sleepless (Daytime only)
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
cough comes back or occurs with 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

take only as recommended – see Liver warning
take Nighttime or Daytime
use dose cup

Nighttime Liquid

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

Daytime Liquid

do not exceed 5 doses (children) or 6 doses (adults) per 24 hours

adults and children 12 years and over	30 mL (2 TBSP) every 4 hours
children 6 to under 12 years	15 mL (1 TBSP) every 4 hours
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

each TBSP of Nighttime contains: sodium 18 mg
each TBSP of Daytime contains: sodium 7 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

Nighttime alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Daytime butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavors, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Save when you buy Daytime & Nighttime Relief compared to buying individually

Compare to the active ingredients in Vicks® DayQuil® and Vicks® NyQuil®

Multi-Symptom

Cold/Flu Relief

Do Not Use if Printed Neckband is Broken or Missing

DAYTIME PDP TEXT

See New Warnings Information

Non-Drowsy

DayTime

Alcohol Free

Antihistamine Free

Relieves congested-stuffy head, sore throat, coughing, aching, and fever so you can get through the day

Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant

Acetaminophen - Aches, Fever

Dextromethorphan HBr - Cough

Phenylephrine HCl - Nasal Congestion

NIGHTTIME PDP TEXT

See New Warnings Information

Multi-Symptom

NightTime

Original Flavor

Alcohol 10%

Helps relieve coughing, sniffles, and aches and pains due to the common cold while you sleep.

Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine

Acetaminophen - Aches, Fever

Dextromethorphan HBr - Cough

Doxylamine succinate - Sneezing, Runny Nose

Daytime and Nighttime Cold/Flu Relief Combo Pack Carton

DAYTIME NIGHTTIME MULTI SYMPTOM COLD FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	59779-912

Packaging
#	NDC	Package Description	Multilevel Packaging
1	59779-912-01	1 KIT In 1 PACKAGE, COMBINATION	None

QUANTITY OF PARTS
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	295 mL
Part 2	1 BOTTLE	295 mL

Part 1 of 2

NIGHTTIME MULTI SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
NDC Product Code (Source)	59779-908
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg in 15 mL
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
No Inactive Ingredients Found

Product Characteristics
Color	GREEN (bright, clear)	Score
Shape		Size
Flavor	ANISE	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	59779-908-38	295 mL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341

Part 2 of 2

DAYTIME NON DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
NDC Product Code (Source)	59779-656
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	5 mg in 15 mL

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	ORANGE (clear)	Score
Shape		Size
Flavor	MENTHOL (strong menthol, weak fruit)	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	59779-656-38	295 mL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/02/2006

Labeler - CVS Pharmacy (062312574)

Revised: 06/2009CVS Pharmacy