FDA Label for Daytime Cold And Flu Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 15 ML)
- PURPOSES
- 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
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Daytime Cold And Flu Relief 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 15 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
• temporarily relieves common cold/flu symptoms:• nasal congestion• cough due to minor throat and bronchial irritation• minor aches and pains• headache• fever• sore throat
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
• adult takes more than 4 doses (30 mL) in 24 hrs which is maximum daily amount for this product• child takes more than 4 doses (15 mL) in 24 hours, which is the maximum daily amount for this product• taken with other drugs containing acetaminophen• adult has 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.
Do Not Use
• with any other drug containing acetaminophen (prescription or non-prescription). 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.
Ask A Doctor Before Use If You Have
• liver disease• heart disease• high blood pressure• thyroid disease• diabetes• trouble urinating due to an enlarged prostate gland• cough that occurs with too much phlegm (mucus)• persistent or chronic cough such as occurs with smoking, asthma, or emphysema• a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
When Using This Product,
do not use more than directed.
Stop Use And Ask A Doctor If
• you get nervous, dizzy, or sleepless• pain, nasal congestion or cough gets worse, or lasts more than 5 days (children) or 7 days (adults)• fever gets worse or lasts more than 3 days• redness or swelling is present• new symptoms occur• cough comes back or occurs with a 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
• take only as directed• only use the dose cup provided• do not exceed 4 doses per 24 hours
Adults & children 12 yrs & over | 30 mL every 4 hrs. |
Children 6 to under 12 yrs | 15 mL every 4 hrs |
Children 4 to under 6 yrs | Ask a doctor |
Children under 4 yrs. | Do not use |
Other Information
• each 15 mL contains: sodium 42 mg• store at room temperature. Do not refrigerate
Inactive Ingredients
Anhydrous citric acid, disodium edetate, FD&C Yellow No 6, flavors, glycerin, menthol, potassium citrate, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-866-467-2748
Principal Display Panel
Compare to the active ingredients in VICKS® Dayquil™ Cold & Flu*
NDC 51316-617-12
Day Time
Cold & Flu Relief
Acetaminophen, Phenylephrine HCI,
Dextromethorphan HBr
For Relieves of
• Headache, Fever, Sore Throat, Minor Aches & Pains• Nasal congestion & Sinus Pressure• Cough
12 FL OZ (354 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Distributed by:
*This product.is not manufactured or distributed by Procter & Gamble, distributer of Vicks® Dayquil™ Cold & Flu.
* Please review the disclaimer below.