FDA Label for Day Time Cold And Flu Cold And Flu Multi Symptom Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 15 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
- 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
Day Time Cold And Flu Cold And Flu Multi Symptom Relief Product Label
The following document was submitted to the FDA by the labeler of this product We Care Distributor Inc.. 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
Purpose
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• sore throat• headache• minor aches and pains• fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes
• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or followed by fever, headache, rash, nausea, or vomiting, see 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.
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough 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
Stop Use And Ask A Doctor If
- you get nervous, dizzy or sleepless
- new symptoms occur
- redness or swelling is present
- symptom gets worse or lasts more than 5 days (children) or 7 days (adults)
- fever gets worse or lasts more than 3 days
- 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.
Overdose warning: Taking more than directed cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center 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 – see Overdose warning
- use dose cup
- do not exceed 4 doses per 24 hrs
adults & children 12 years and over: 30 mL every 4 hrs
children 6 to under 12 years: 15 mL every 4 hrs
children under 12 years: ask a doctor
When using Day Time and Night Time products; carefully read each label to ensure correct dosing
Other Information
- protect from freezing
- each tablespoon contains: sodium 46 mg
- store at room temperature 15-30°C (59-86°F)
Inactive Ingredients
citric acid, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose
Questions Or Comments?
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
Principal Display Panel
SEE NEW WARNINGS
Compare to DayQuil® Cold & Flu Active Ingredients
Non-Drowsy
DayTime Cold & Flu
Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant Multi-Symptom Relief
Aches, fever - Acetaminophen
Cough - Dextromethorphan HBr
Nasal congestion - Phenylephrine HCl
Alcohol Free and Antihistamine Free
4 FL OZ (120 mL)
* Please review the disclaimer below.