FDA Label for Severe Cold And Flu Relief Daytime/nighttime
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPLET) (DAYTIME COLD & FLU SEVERE)
- PURPOSE
- ACTIVE INGREDIENTS (IN EACH CAPLET) (NIGHTTIME COLD & FLU SEVERE)
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS (DAYTIME ONLY)
- INACTIVE INGREDIENTS (NIGHTTIME ONLY)
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Severe Cold And Flu Relief Daytime/nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Caplet) (Daytime Cold & Flu Severe)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Active Ingredients (In Each Caplet) (Nighttime Cold & Flu Severe)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- sore throat
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure (Nighttime only)
- sneezing and runny nose (Nighttime only)
- helps clear nasal passages (Nighttime only)
- relieves cough to help you sleep (Nighttime only)
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive (Daytime only)
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hours, which is the maximum daily amount
- 3 or more alcoholic drinks every day while using this product
- with other drugs containing acetaminophen
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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. - 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
- thyroid disease
- diabetes
- high blood pressure
- heart disease
- glaucoma (Nighttime only)
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
- be careful when driving a motor vehicle or operating machinery (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness(Nighttime only)
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
If taking NIGHTTIME and DAYTIME products, carefully read
each section to ensure correct dosing.
Directions
- do not take more than directed
- adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole – do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
- take 2 caplets every 4 hours
- children under 12 years: ask a doctor
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients (Daytime Only)
corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Inactive Ingredients (Nighttime Only)
corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Questions Or Comments?
1-800-426-9391
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Compare to the active ingredients in
Tylenol® COLD + FLU SEVERE Day & Night*
DAYTIME - Non-Drowsy
Severe Cold
& Flu Relief
ACETAMINOPHEN - Pain reliever, Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
GUAIFENESIN - Expectorant
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Fever, Headache, Sore throat,
Nasal congestion, Cough, Mucus,
Chest congestion
16 CAPLETS
NIGHTTIME
Severe Cold
& Flu Relief
ACETAMINOPHEN - Pain reliever, Fever reducer
CHLORPHENIRAMINE MALEATE - Antihistamine
DEXTROMETHORPHAN HBr - Cough suppressant
PHENYLEPHRINE HCI - Nasal decongestant
Relieves:
Fever, Headache, Sore throat,
Runny nose, Cough,
Nasal congestion
8 CAPLETS
Actual Size
24 TOTAL CAPLETS
*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark Tylenol®
COLD + FLU SEVERE Day & Night.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844
ORG031650347308
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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