Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE PRODOSE, INC. FDA Approved Uses Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each Softgel) Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg
Inactive Ingredients
Inactive ingredients D&C yellow no. 10 gelatin glycerin polyethylene glycol 400 povidone k 30 propylene glycol purified water sorbitol sorbitan solution
Strengths
325 mg 10 mg 5 mg
Treats Conditions
Uses Temporarily Relieves Common Cold Flu Symptoms Nasal Congestion Cough Due To Minor Throat Bronchial Irritation Sore Throat Headache Minor Aches Pains Fever
Pill Appearance
Shape: capsule Color: yellow Imprint: 41

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ
Packaging

Bulk Label

Package Descriptions
  • Bulk Label

Overview

Uses Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

Indications & Usage

Uses Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

Dosage & Administration

Directions take only as directed do not exceed 8 Softgels per 24 hrs adults & children 12 years & over 2 Softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product 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: skin reddening blisters rash 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.
Purpose

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

Do Not Use

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.

When Using

When using this product, do not use more than directed.

Stop Use & Ask a Doctor

Stop use and ask a doctor if you get nervous, dizzy or sleepless 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 cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children 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.


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