FDA Label for Cold And Flu Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 15 ML)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE USER HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE USER IS
- 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
Cold And Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product L.n.k. International, 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 and flu symptoms:
- sore throat
- nasal congestion
- fever
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- child takes more than 5 doses in 24 hours
- 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.
- 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 The User Has
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- heart disease
- liver disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- high blood pressure
Ask A Doctor Or Pharmacist Before Use If The User 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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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 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
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- do not take more than 5 doses per 24 hours
adults and children 12 years and over | 30 mL every 4 hours |
children 6 to under 12 years | 15 mL every 4 hours |
children under 6 years | do not use |
Other Information
- each 15 mL contains: sodium 13 mg
- use by expiration date on package
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
anhydrous citric acid, FD&C yellow #6, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sodium saccharin, sorbitol, sucralose
Questions Or Comments?
1-800-426-9391
Principal Display Panel
QUALITY
+PLUS
NDC 50844-120-45
Compare to active ingredients
in Vicks® DayQuil® Cold & Flu
Multi-Symptom Relief*
Multi-Symptom
COLD & FLU RELIEF
Acetaminophen,
Dextromethorphan HBr,
Phenylephrine HCl
PAIN RELIEVER/FEVER REDUCER
COUGH SUPPRESSANT
NASAL DECONGESTANT
DAYTIME
Non-Drowsy
Alcohol Free
Menthol
Flavor
6 FL OZ (177 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Procter & Gamble,
owner of the registered trademark Vicks® DayQuil® Cold & Flu
Multi-Symptom Relief. 50844 REV0318A01245
Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
PARENTS:
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* Please review the disclaimer below.