Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Cold And Flu Kit
FDA Label NDC 51316-123
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Woonsocket Prescription Center, Incorporated for the product Cold And Flu (NDC 51316-123). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 15 ml), purpose, uses, warnings, do not use, ask a doctor before use if the user has, ask a doctor or pharmacist before use if the user is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- nasal congestion
- minor aches and pains
- cough due to minor throat and bronchial irritation
- headache
- temporarily reduces fever
- temporarily relieves common cold and flu symptoms:
- headache
- minor aches and pains
- sore throat
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. 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
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
- 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
- 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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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
- 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 The User Has
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- heart disease
- diabetes
- thyroid disease
- liver disease
- high blood pressure
Ask A Doctor Or Pharmacist Before Use If The User Is
taking the blood thinning drug warfarin.
When Using This Product
do not exceed recommended dosage.
- excitability may occur, especially in children
- avoid alcoholic beverages
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- 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.
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
In case of overdose, get medical help or contact a Poison Control Center right away. 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 take more than directed
- do not exceed 4 doses per 24 hours
- mL = milliliter
- only use the dose cup provided
- do not take more than directed
- do not exceed 4 doses per 24 hours
- mL = milliliter
- only use the dose cup provided
- adults and children 12 years and over: 30 mL every 6 hours
- children under 12 years: do not use
| adults and children 12 years and over | 30 mL every 4 hours |
| children 6 to under 12 years | 15 mL every 4 hours |
| children under 6 years | do not use |
Other Information
- each 15 mL contains: sodium 13 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
- each 30 mL contains: sodium 13 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, polyethylene glycol 400, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose
Questions Or Comments?
1-800-426-9391
1-800-426-9391
Active Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Ask A Doctor Before Use If You Have
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- liver disease
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Principal Display Panel
COMBO PACK
♥CVS Compare to the active Daytime ACETAMINOPHEN Relieves: No added alcohol 2 – 12 FL OZ | ♥CVS Compare to the active Nighttime ACETAMINOPHEN Relieves: Cherry Flavor TOTAL 24 FL OZ |
TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
*This product is not manufactured
or distributed by The Procter &
Gamble Company, owner of the
registered trademarks Vicks®
DayQuil® Cold & Flu and Vicks®
NyQuil® Cold & Flu.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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CVS.com® 1-800-SHOP CVS V-19849
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guaranteed
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50844
ORG032301201302
Cvs 44-012013 (Cvs 44 012013 1)
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