Quality Plus 44-012 Delisted
Cold and Flu Relief by
Drug Labeling and Warnings
Cold and Flu Relief by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, phenylephrine hcl solution
L.N.K. International, Inc.
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Quality Plus 44-012 Delisted
Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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
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.
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
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:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Quality Plus 44-012
| COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl solution |
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| Labeler - L.N.K. International, Inc. (038154464) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 967626305 | manufacture(50844-120) , pack(50844-120) | |