Label: COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, phenylephrine hcl solution
- NDC Code(s): 50844-120-45
- Packager: L.N.K. International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 15 mL)
- Purpose
- Uses
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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.
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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
- Inactive ingredients
- Questions or comments?
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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 RELIEFAcetaminophen,
Dextromethorphan HBr,
Phenylephrine HClPAIN RELIEVER/FEVER REDUCER
COUGH SUPPRESSANT
NASAL DECONGESTANTDAYTIME
Non-Drowsy
Alcohol FreeMenthol
Flavor6 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 REV0318A01245Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USAPARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Quality Plus 44-012
-
INGREDIENTS AND APPEARANCE
COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-120 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color orange Score Shape Size Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50844-120-45 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/28/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/28/2022 Labeler - L.N.K. International, Inc. (038154464) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 manufacture(50844-120) , pack(50844-120)