FDA Label for Flu And Severe Cold Daytime Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 30 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
- PRODUCT LABEL
Flu And Severe Cold Daytime 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 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves these symptoms due to a cold
- minor aches and pains
- headache
- nasal congestion
- sore throat
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may inclide:
- skin reddening
- blisters
- rash
- more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
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
- 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.
- with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- cough accompanied by excessive phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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 (see overdose warning)
Stop Use And Ask A Doctor If
- redness or swelling is present
- new symptoms occur
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with a fever, 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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick 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 (see overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- mL= milliliter
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL every 4 hours
- chlldren under 12 years of age: do not use
Other Information
- each 30 mL contains: sodium 16 mg
- store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, maltito, propylene glycol, purified water, sodium benzoate, sodium citrate
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Daytime Relief
Flu & Severe Cold
Acetaminophen
Pain reliever, fever reducer
Dextromethorphan HBr
Cough suppressant
Phenylephrine HCl
Nasal decongestant
Relief of:
Nasal congestion; cough; fever; body ache; sore throat; headache
Alcohol Content: 10%
Cherry Flavor
For ages 12 & over
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
Failure to follow the drug facts warnings could result in serious consequences.
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Theraflu® Daytime Severe Cold & cough.
Product Label
CVS Flu & Severe Cold Liquid
* Please review the disclaimer below.