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Acetaminophen, Phenylephrine Hydrochloride

OTC Oral RxCUI 1052670
Contents

Overview

Active ingredient
Acetaminophen, Phenylephrine Hydrochloride
Route
Oral
Label date
2025-03-18

Indications and usage

Uses Temporarily relieves symptoms due to the common cold (or a cold) minor aches and pains headache fever nasal congestion sinus congestion & pressure temporarily relieves symptoms due to hay fever or other respiratory allergies

Purpose

Active ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain Reliever-Fever reducer Phenylephrine HCl 5 mg Nasal Descongestant

Dosage and administration

Directions take only as directed (see overdose warning) do not exceed 8 softgels per 24 hrs adults and children 12 years and over 2 softgels with water every 4 hours children 4 to under 12 years consult a doctor children under 4 years do not use

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 Softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptomsmay include: skin reddening blisters rash. If a skin reaction occurs, stop use and seek medical help right away. 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, psyciatric 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. Ask a doctor or pharmacist before use if you are Taking the blood thinning drug warfarin. Ask a doctor before use if you have liver disease heart disease hight blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland When using this product do not use more than directed Stop use and ask a doctor if pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur you get nervous, dizzy or sleepless Keep out of reach of children Keep out of reach of children If pregnant or breast-feeding, ask a health professional before use. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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, psyciatric 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.

Ask a doctor before use if

Ask a doctor before use if you have liver disease heart disease hight blood pressure thyroid disease diabetes trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are Taking the blood thinning drug warfarin.

When using this product

this product do not use more than directed

Stop use and ask a doctor if

and ask a doctor if pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur you get nervous, dizzy or sleepless

Overdosage

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Pregnancy or breast-feeding

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

Active ingredient (label)

s Purpose Active ingredients (in each softgel) Purpose Acetaminophen 325 mg Pain Reliever-Fever reducer Phenylephrine HCl 5 mg Nasal Descongestant

Inactive ingredients

s FD&C yellow no.6, Gelatin, Glycerin, Methylparaben, Polyethylene glycol 400, Povidone K 30, Propylene glycol, Propyparaben, Purified water, Sorbitol, Titanium Dioxide.

Storage and handling

Other information Do not exceed 25°C TAMPER EVIDENT:This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors .

Keep out of reach of children

of children Keep out of reach of children