Active Ingredients (In Each Caplet) (Daytime Cold & Flu Severe)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by L.n.k. International, Inc. for the product Cold And Flu (NDC 50844-547). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet) (daytime cold & flu severe), purpose, active ingredients (in each caplet) (nighttime cold & flu severe), uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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.
ask a health professional before use.
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.
Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.
corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
1-800-426-9391
QUALITY
PLUS
NDC 50844-547-08
*Compare to active ingredients in
Tylenol® COLD + FLU
SEVERE DAY & NIGHT
SEVERE
COLD & FLU
DAY
Acetaminophen,
Dextromethorphan HBr,
Guaifenesin
Phenylephrine HCl
PAIN RELIEVER/
FEVER REDUCER,
COUGH SUPPRESSANT,
EXPECTORANT,
NASAL DECONGESTANT
ACTUAL
SIZE
16
Caplets
NIGHT
Acetaminophen,
Chlorpheniramine maleate,
Dextromethorphan HBr,
Phenylephrine HCl
PAIN RELIEVER/
FEVER REDUCER,
ANTIHISTAMINE,
COUGH SUPPRESSANT,
NASAL DECONGESTANT
ACTUAL
SIZE
8
Caplets
24 Total Caplets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT
IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Tylenol® COLD + FLU SEVERE DAY & NIGHT.
50844 ORG071850347308
PARENTS:
Learn About Teen Medicine Abuse
www.StopMedicineAbuse.org
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788 USA
* Please review the disclaimer below.