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← See all CVS Health Nighttime Severe Cough and Cold Nighttime Severe Cold and Cough brands

CVS Health Nighttime Severe Cough and Cold Nighttime Severe Cold and Cough

Medically reviewed on Dec 30, 2017

Dosage form: powder, for solution
Ingredients: ACETAMINOPHEN 650mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: CVS Pharmacy,Inc.
NDC Code: 59779-876

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.

CVS Health Nighttime Severe Cough and Cold 12 Packets

Active ingredients (in each packet)

Acetaminophen, 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever / fever reducer

Antihistamine / Cough Suppressant

Nasal Decongestant

Uses
temporarily relieves these symptoms due to a cold:
minor aches and pains
minor sore throat pain
headache
nasal and sinus congestion
runny nose
sneezing
itchy nose or throat
itchy, watery eyes due to hay fever
cough due to minor throat and bronchial irritation
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Do not use
in a child under 4 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
with any other product containing diphenhydramine, even one used on the skin
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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a sodium-restricted diet
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema, asthma or chronic bronchitis
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

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

When using this product
do not exceed recommended dosage
avoid alcoholic drinks
marked drowsiness may occur
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
symptoms do not get better or worsen
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with fever, rash or headache that lasts. There could be signs of a serious condition.

If pregnant or breast- feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
do not use more than directed
take every 4 hours; not to exceed 5 packets in 24 hours or as directed by a doctor

Age

Dose

children under 4 years of age

do not use

children 4 to under 12 years of age

do not use unless directed by a doctor

adults and children 12 years of age and over

one packet

dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

Other information
each packet contains: potassium 6 mg
store at controlled room temperature 20o -25oC (68o-77oF). Protect from excessive heat and moisture.

Inactive ingredients

citric acid, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose, yellow#6

Questions or comments?

1-866-467-2748

Additional Information Listed On Other Panels

CVS Health

Compare to the active ingredients in Theraflu® Nighttime Severe Cold &Cough*

Severe

NDC 59779-876-12

NIGHTTIME

Severe Cough & Cold

ACETAMINOPHEN

Pain reliever; Fever reducer

DIPHENHYDRAMINE HCl

Antihistamine; Cough suppressant

PHENYLEPHRINE HCl

Nasal decongestant

Relieves:

Nasal congestion
Sore throat pain
Cough
Headache
Body ache
Fever

Honey Lemon Flavor Infused with Chamomile & White Tea Flavors

12 PACKETS

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD,

NIGHTTIME Severe Cough & Cold

CVS Health™ Nighttime Severe Cough & Cold provides complete relief of your cough and severe cold symptoms. This soothing hot liquid formula is alcohol free and tastes great.

For daytime relief, try CVS Health™ Daytime Severe Cough & Cold.

TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2015 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-12431

CVS Quality

Money back Guarantee

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Theraflu® Nighttime Severe Cold & Cough.

Principal Display
CVS HEALTH NIGHTTIME SEVERE COUGH AND COLD  NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine, phenylephrine powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-876
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
MALTODEXTRIN 
POTASSIUM CHLORIDE 
SILICON DIOXIDE 
SUCRALOSE 
SUCROSE 
FD&C YELLOW NO. 6 
Product Characteristics
Color    Score    
ShapeSize
FlavorHONEY, LEMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-876-1212 POWDER, FOR SOLUTION in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/17/2015
Labeler - CVS Pharmacy,Inc. (062312574)

 
CVS Pharmacy,Inc.

← See all CVS Health Nighttime Severe Cough and Cold Nighttime Severe Cold and Cough brands

Further information

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

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