Active Ingredients (In Each Caplet) (Daytime Cold Multi-Symptom)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Cold Relief Kit
FDA Label NDC 50844-529
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by L.n.k. International, Inc. for the product Cold Relief (NDC 50844-529). 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 multi-symptom), purpose, active ingredients (in each caplet) (nighttime cold multi-symptom), 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.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Active Ingredients (In Each Caplet) (Nighttime Cold Multi-Symptom)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- headache
- sore throat
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- sneezing and runny nose (Nighttime only)
- helps clear nasal passages
- promotes nasal and sinus drainage
- relieves cough to help you sleep
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- 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 You Have
- diabetes
- liver disease
- high blood pressure
- heart disease
- glaucoma (Nighttime only)
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- difficulty in urination due to enlargement of the prostate gland
- thyroid disease
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
- use caution when driving a motor vehicle or operating machinery (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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 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.
Do not take DAYTIME and NIGHTTIME products at the same time.
Directions
- do not take more than directed
- adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole – do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
- children under 12 years: ask a doctor
Other Information
- each caplet contains: sodium 3 mg (Nighttime only)
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients (Daytime Only)
corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
Inactive Ingredients (Nighttime Only)
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
Questions Or Comments?
1-800-426-9391
Principal Display Panel
QUALITY
+PLUS
NDC 50844-529-09
MULTI-SYMPTOM
COLD RELIEF
Acetaminophen, PAIN RELIEVER/FEVER REDUCER, ACTUAL 12 Caplets | Acetaminophen, PAIN RELIEVER/FEVER REDUCER, ACTUAL 8 Caplets |
20 Total Caplets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Do Not Take Daytime and
Nighttime Products at the
Same Time.
50844 ORG112247047309
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
Quality Plus 44-470c473c (Quality Plus 44 470c473c 09 1)
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