MAXIMUM STRENGTH COLD AND FLU ACETAMINOPHENDEXTROMETHORPHAN HYDROBROMIDEGUAIFENESINPHENYLEPHRINE HYDROCHLORIDE CVS PHARMACY, INC FDA Approved Uses Temporarily relieves these common cold and flu symptoms: nasal congestion headache cough minor aches and pains sore throat temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients FD&C yellow no. 6 gelatin glycerin polyethylene glycol povidone propylene glycol purified water shellac sorbitol sorbitan solution titanium dioxide
Strengths
325 mg 10 mg 200 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Common Cold And Flu Symptoms Nasal Congestion Headache Cough Minor Aches And Pains Sore Throat Temporarily Reduces Fever Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus And Make Coughs More Productive
Pill Appearance
Shape: oval Color: orange Imprint: 78

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
Packaging

628T-CVS-ColdFlu-16s-ifc

Package Descriptions
  • 628T-CVS-ColdFlu-16s-ifc

Overview

Uses Temporarily relieves these common cold and flu symptoms: nasal congestion headache cough minor aches and pains sore throat temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Indications & Usage

Uses Temporarily relieves these common cold and flu symptoms: nasal congestion headache cough minor aches and pains sore throat temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Dosage & Administration

Directions do not take more than directed (see Overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and older: take 2 softgels every 4 hours children under 12 years of age: do not use

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 softgels in 24 hrs, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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

Purposes Pain reliever/fever reducer Cough suppressant Expectorant 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 nervousness, dizziness, or sleeplessness occur 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 fever, 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. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Questions

Questions? call 1-877-290-4008


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