Active Ingredients (In Each 20 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Triprolidine HCl 2.5 mg
Cold And Flu Solution
FDA Label NDC 51316-963
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 51316-963). 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 20 ml), purpose, 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, 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
Antihistamine
Uses
- temporarily relieves these common cold and flu symptoms:
- headache
- minor aches and pains
- sneezing
- runny nose
- itching of the nose or throat
- cough
- sore throat
- itchy, watery eyes due to hay fever
- temporarily reduces fever
- controls cough to help you get to sleep
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- 3 or more alcoholic drinks every day while using this product
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- rash
- blisters
- skin reddening
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
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children
- alcohol, sedatives, and tranquilizers may increase drowsiness
- marked drowsiness may occur
- use caution when driving a motor vehicle or operating machinery
- avoid alcoholic beverages
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
- new symptoms occur
- 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 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 take more than 4 doses in any 24-hour period
- mL = milliliter
- only use the dose cup provided
- adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years: do not use
Other Information
- 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 blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum
Questions Or Comments?
1-800-426-9391
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♥CVS
Health®
Compare to the active
ingredients in Mucinex®
Nightshift® Cold & Flu*
Nighttime
Cold & Flu
ACETAMINOPHEN - Pain reliever/Fever reducer
DEXTROMETHORPHAN HBr - Cough suppressant
TRIPROLIDINE HCl - Antihistamine
MULTI-SYMPTOM
Controls cough
Relieves fever & sore throat
Relieves runny nose & sneezing
FOR AGES 12+
6 FL OZ (177 mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
*This product is not manufactured or
distributed by RB Health (US) LLC, owner
of the registered trademark Mucinex®
Nightshift® Cold & Flu.
B-063-45 REV0423A
50844 REV0423A06345
Distributed by: CVS Pharmacy, Inc., One CVS Drive
Woonsocket, RI 02895 © 2023 CVS/pharmacy V-19849
Cvs 44-063 (Cvs 44 063 1)
* Please review the disclaimer below.
