Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 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 Allergy (NDC 50844-455). 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), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg
Pain reliever
Antihistamine
Nasal decongestant
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
headache
nasal congestion
runny nose and sneezing
minor aches and pains
temporarily relieves these additional symptoms of hay fever:
itchy, watery eyes
helps clear nasal passages
helps decongest sinus openings and passages
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 4,000 mg in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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
difficulty in urination due to enlargement of the prostate gland
glaucoma
high blood pressure
a breathing problem such as emphysema or chronic bronchitis
heart disease
thyroid disease
liver disease
taking the blood thinning drug warfarin
taking sedatives or tranquilizers
do not exceed recommended dosage
excitability may occur, especially in children
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery
may cause drowsiness
nervousness, dizziness, or sleeplessness occur
pain or nasal congestion 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
ask a health professional before use.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 more than directed
(see overdose warning)
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
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
corn starch, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
1-800-426-9391
QUALITY
+ PLUS
NDC 50844-455-08
*Compare to active ingredients in Tylenol® Allergy Multi-Symptom
Allergy
Multi-Symptom
Acetaminophen
Chlorpheniramine maleate
Phenylephrine HCl
PAIN RELIEVER, ANTIHISTAMINE,
NASAL DECONGESTANT
• Headache • Sinus Pressure
• Runny Nose • Nasal Congestion
• Sneezing • Itchy, Watery Eyes
24 Caplets Pseudoephedrine Free ACTUAL SIZE
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 McNeil Consume Healthcare, owner of the registered trademark Tylenol® Allergy Multi-Symptom.
50844 ORG061645508
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA
* Please review the disclaimer below.