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nighttime cold flu relief

Dosage form: capsule, gelatin coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, DOXYLAMINE SUCCINATE 6.25mg
Labeler: CVS Pharmacy
NDC code: 59779-803

CVS Pharmacy, Inc. NightTime Cold/Flu Relief Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
fever
runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 8 softgels (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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 this product.
to make a child sleepy
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have
liver disease
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
persistent or chronic cough as occurs with smoking, asthma, or emphysema
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product
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
pain or cough gets worse or lasts more than 7 days
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
do not exceed 8 softgels per 24 hours

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 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

Inactive Ingredients

D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients in Vicks® NyQuil®

Multi-Symptom

NIGHTTIME

COLD/FLU RELIEF

Antihistamine, Pain reliever, Cough suppressant, Fever reducer

Acetaminophen – aches, fever

Dextromethorphan HBr – cough

Doxylamine succinate – sneezing, runny nose

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

24 Softgels

NIGHTTIME COLD FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-803
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
Product Characteristics
ColorGREEN (clear) Scoreno score
ShapeCAPSULESize20mm
FlavorImprint Code056
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-803-6212 BLISTER PACK in 1 CARTON
12 CAPSULE, GELATIN COATED in 1 BLISTER PACK
2NDC:59779-803-6724 BLISTER PACK in 1 CARTON
22 CAPSULE, GELATIN COATED in 1 BLISTER PACK
3NDC:59779-803-738 BLISTER PACK in 1 CARTON
32 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/21/2014
Labeler - CVS Pharmacy (062312574)

Revised: 03/2014
 
CVS Pharmacy

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.