MAXIMUM STRENGTH COLD AND FLU (phenylephrine hydrochloride 5 mg acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg) Dailymed
Generic: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Bronchitis Common Cold Laryngitis Pharyngitis Rhinitis, Allergic, Perennial Sinusitis Whooping Cough Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular
IMPRINT: 78
SHAPE: oval
COLOR: orange
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Otc - Active Ingredient Section
Active ingredients (in each softgel)
acetamnophen 325 mg
Dextromethorphan HBr 10mg
Gualifenesin 200 mg
Phenylephrine HCl 5 mg
Otc - Purpose Section
Purpose
- Pain reliever/fever reducer
- Cough suppressant
- Expectorant
- Nasal decongestant
Indications & Usage Section
Uses
temporarily relieves these common cold/flu symptoms:
- nasal congestion
- headache
- cough
- minor aches & pains
- sore throat
temporarily reduces fever
promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings Section
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 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. Symptoms may include:
- skin reddening
- bulers
- 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.
Otc - Do Not Use Section
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.
Otc - Ask Doctor Section
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Otc - Ask Doctor/pharmacist Section
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Otc - When Using Section
When using this product do not use more than directed.
Otc - Stop Use Section
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.
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children Section
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.
Dosage & Administration Section
Directions • Do not take more than directed (see Overdose warning) • do not exceed 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
Storage And Handling Section
Other information
- store at 20-25°C (68-77°F)
- avoid excessive heat
Otc - Questions Section
Questions?
Call 1-877-290-4008
Inactive Ingredient Section
Inactive ingredients FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Package Label.principal Display Panel
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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