CVS Health Nighttime Severe Cough and Cold 12 Packets
Drug Labeling and Warnings
Drug Details [pdf]
CVS HEALTH NIGHTTIME SEVERE COUGH AND COLD NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, diphenhydramine, phenylephrine powder, for solution
CVS Pharmacy,Inc.
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 Health Nighttime Severe Cough and Cold 12 Packets
Active ingredients (in each packet)
Acetaminophen, 650 mg
Diphenhydramine hydrochloride 25 mg
Phenylephrine hydrochloride 10 mg
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.
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
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.
| CVS HEALTH NIGHTTIME SEVERE COUGH AND COLD
NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, diphenhydramine, phenylephrine powder, for solution |
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| Labeler - CVS Pharmacy,Inc. (062312574) |
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