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 Dolgencorp, Llc for the product Allergy Multi-symptom (NDC 55910-455). 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:
temporarily relieves these additional symptoms of hay fever:
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
diabetes
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
adults and children 12 years and over
swallow whole - do not crush, chew, or dissolve
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
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Compare to active ingredients of Tylenol® Allergy Multi-Symptom*
Allergy
Multi-Symptom
Acetaminophen 325 mg
Chlorpheniramine Maleate 2 mg
Phenylephrine HCl 5 mg
Pain Reliever, Antihistamine,
Nasal Decongestant
Relieves:
• Headache, sinus pressure
• Nasal congestion, runny nose
• Sneezing & itchy, watery eyes
Pseudoephedrine Free
24 Caplets
Actual Caplet Size
Cool Blast Flavor
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 Consumer Healthcare, owner of the registered trademark Tylenol® Allergy Multi-Symptom.
50844 REV0616B45508
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
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* Please review the disclaimer below.