Active Ingredients (In Each 10 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Multi-symptom Cold And Fever Solution
FDA Label NDC 69842-475
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 Pharmacy for the product Multi-symptom Cold And Fever (NDC 69842-475). 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 10 ml), purpose, uses, warnings, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if your child 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
Expectorant
Nasal decongestant
Uses
- temporarily relieves common cold and flu symptoms:
- minor aches and pains
- sore throat
- headache
- stuffy nose
- the intensity of coughing
- nasal congestion
- cough due to minor throat and bronchial irritation
- the impulse to cough to help your child get to sleep
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
- more than 5 doses in 24 hours, which is the maximum daily amount
- 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.
- in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
- if your child has ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If The Child Has
- liver disease
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If Your Child Is
taking the blood thinning drug warfarin.
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 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.
Keep Out Of Reach Of Children.
In case of accidental 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
- this product does not contain directions or complete warnings for adult use
- do not give more than 5 doses in any 24-hour period
- mL = milliliter; FL OZ = fluid ounce
- only use the dose cup provided
- repeat dose every 4 hours while symptoms last
- dose as follows or as directed by a doctor
- children 6 to under 12 years: 10 mL in dosing cup provided
- children under 6: do not use
Other Information
- each 10 mL contains: sodium 5 mg
- 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
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose
Questions Or Comments?
1-800-426-9391
Principal Display Panel
♥CVS
Health®
Children’s
Multi-Symptom
Cold & Fever
ACETAMINOPHEN 325 mg
Pain reliever/Fever reducer
DEXTROMETHORPHAN HBr 10 mg
Cough suppressant
GUAIFENESIN 200 mg
Expectorant
PHENYLEPHRINE HCl 5 mg
Nasal decongestant
Relieves:
Minor aches & pains, Fever, Cough,
Nasal congestion, Chest congestion,
Stuffy nose, Thins & loosens mucus
Alcohol free
Mixed Berry Flavor Liquid
Ages 6 to 12 Years
4 FL OZ (118 mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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50844 ORG042107536
Cvs 44-075 (Cvs 44 075 1)
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