Allergy Relief Multisymptom
FDA Label NDC 52904-457

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Allergy Relief Multisymptom (NDC 52904-457). 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 otc - active ingredient, otc - purpose, dosage & administration, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Acetaminophen 325 mg.......................Pain Reliever/Fever Reducer
Chlorpheniramine Maleate 2 mg.............................Antihistamine
Phenylephrine HCl 5 mg.............................Nasal Decongestant



Otc - Purpose

Pain Reliever, Fever Reducer, Antihistamine, Nasal Decongestant

Dosage & Administration

Directions: Adults and children 12 years of age and older • take 2
tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or
as directed by a doctor • Children under 12 years, consult a doctor

Indications & Usage

Uses: Temporarily: • relieves nasal congestion associated with sinusitis
• relieves nasal congestion due to the common cold, hay fever or other
upper respiratory allergies • relieves sinus congestion and pressure,
helps decongest sinus openings and passages • restores free breathing
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial passages of bothersome mucus, drain bronchial tubes, and
make coughs more productive • Temporarily relieves minor aches, pains,
and fever associated with: • headache • common cold • toothache
• backache • muscular aches • menstrual cramps

Warnings

Warnings: Liver Warning: Thisproduct contains acetaminophen. Severe liver damage may occur ifyou take: • more than 8 tablets in 24 hours • with other drugs containingacetaminophen (prescription or nonprescription). Ask a doctor orpharmacist before using with other drugs if you are not sure. • 3 or morealcoholic drinks every day while using this product Do not: use withany other product containing acetaminophen this will provide morethan the recommended dose (overdose) of acetaminophen and couldcause serious health concerns. • use more than the recommendeddose • for more than 10 days for pain unless directed by a doctor • formore than 3 days for fever unless directed by a doctor • if you are nowtaking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric or emotionalconditions, or Parkinson’s disease), or for 2 weeks afterstopping MAOI drug. If you do not know if your prescriptiondrug contains an MAOI, consult a doctor or pharmacist beforetaking this product. Stop use and ask a doctor if: • symptomsdo not improve • pain or fever persists or gets worse • newsymptoms occur • redness or swelling is present • nervousness,dizziness or sleeplessness occur • symptoms do not improve within 7days or are accompanied by fever Ask a doctor before use if youhave: • heart disease • high blood pressure • thyroid disease • diabetes• difficulty in urination due to enlargement of the prostate gland • a breathingproblem such as emphysema or chronic bronchitis, or if you have glaucomaor difficulty in urination due to enlargement of the prostate gland • may causeexcitability especially in children • may cause drowsiness; alcohol, sedatives,and tranquilizers may increase the drowsiness effect • avoid alcoholicbeverages while taking this product • do not take this product if you aretaking sedatives or tranquilizers, without first consulting your doctor • usecaution when operating machinery.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding baby, ask a health professional
before use.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Inactive Ingredient

Inactive ingredients: FDC Red 40,
Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch
Glycolate, Starch, Stearic Acid

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