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

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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CVS Pharmacy, Inc. DayTime NightTime Multi-Symptom Cold/Flu Relief Drug Facts

Active ingredients for Nighttime (in each 30 ml dose cup)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Active ingredients for Daytime (in each 15 ml tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

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

Warnings

Liver warning: These products contain acetaminophen. The maximum daily dose of these products is 4 doses (2,600 mg acetaminophen) in 24 hours (Nighttime) and 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours (Daytime). Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours, which is the maximum daily amount (Daytime only)
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, lasts for more than 2 days, occurs with or is 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 these products.
to make a child sleepy (Nighttime only)
if you have ever had an allergic reaction to these products or any of their ingredients

Ask a doctor before use if you have

liver disease
heart disease (Daytime only)
thyroid disease (Daytime only)
diabetes (Daytime only)
high blood pressure (Daytime only)
trouble urinating due to an enlarged prostate gland
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 (Nighttime only)
taking the blood thinning drug warfarin

When using these products

do not use more than directed

In addition, when using Nighttime:

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

you get nervous, dizzy or sleepless (Daytime only)
pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) (Daytime only)
pain or cough gets worse or lasts more than 7 days (Nighttime only)
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
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. (1-800-222-1222) 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 directed – see Liver warning
take Nighttime or Daytime
use dose cup
do not exceed 4 doses per 24 hrs

Nighttime

adults & children 12 yrs & over

30 ml (2 TBSP) every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Daytime

adults & children 12 yrs & over

30 ml (2 TBSP) every 4 hrs

children 6 to under 12 yrs

15 ml (1 TBSP) every 4 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use

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

Other information

(Nighttime) each 30 mL dose cup contains: sodium 37 mg
(Daytime) each tablespoon 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, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Package/Label Principal Display Panel

SAVE when you buy Daytime & Nighttime Relief

Compared to buying individually

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

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

Non-Drowsy

DAYTIME

MULTI-SYMPTOM COLD/FLU RELIEF

Pain reliever

Fever reducer

Cough suppressant

Nasal decongestant

Alcohol free

Antihistamine free

Acetaminophen – aches, fever

Dextromethorphan HBr – cough

Phenylephrine HCl – nasal congestion

Multi-Symptom

NIGHTTIME

MULTI-SYMPTOM COLD/FLU RELIEF

Original flavor

ALCOHOL 10%

Pain reliever

Fever reducer

Cough suppressant

Antihistamine

Acetaminophen – aches, fever, sore throat

Dextromethorphan HBr – cough

Doxylamine Succinate – sneezing, runny nose

DayTime NightTime Multi-Symptom Cold/Flu Relief Carton Image 1
DayTime NightTime Multi-Symptom Cold/Flu Relief Carton Image 2
DAYTIME NIGHTTIME  MULTI SYMPTOM COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-567
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-567-021 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 355 mL
Part 21 BOTTLE 355 mL
Part 1 of 2
NIGHTTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
Product Information
Item Code (Source)NDC:59779-335
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ANHYDROUS CITRIC ACID 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
FD&C YELLOW NO. 6 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
Product Characteristics
ColorGREEN (clear, bright green) Score    
ShapeSize
FlavorFRUIT (anise / cooling menthol aroma) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-335-40355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/16/2011
Part 2 of 2
DAYTIME 
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Item Code (Source)NDC:59779-656
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
EDETATE DISODIUM 
FD&C YELLOW NO. 6 
GLYCERIN 
SODIUM PHOSPHATE, MONOBASIC 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SUCROSE 
XANTHAN GUM 
MENTHOL 
Product Characteristics
ColorORANGE (clear) Score    
ShapeSize
FlavorMENTHOL (strong menthol, weak fruit) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-656-40354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/09/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/27/2012
Labeler - CVS Pharmacy (062312574)

Revised: 3/2013
 
CVS Pharmacy