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Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl , is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular

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Drug Facts

Otc - Active Ingredient Section


Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine Hydrochloride 5 mg

Otc - Purpose Section


Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Indications & Usage Section


Uses

temporarily relieves these common cold/flu symptoms: â–  minor aches and pains â–  headache â–  sore throat â–  nasal congestion â–  cough â–  sinus congestion and pressure â–  helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever.

Warnings Section


Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

â–  more than 12 caplets in 24 hours, which is the maximum daily amount

â–  with other drugs containing acetaminophen

â–  3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause a severe skin reactions. Symptoms may include:

â–  skin reddening

â–  bulers

â–  rash

If a skin reaction occurs, stop use and seek medical help immediately.

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 â–  with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. â–  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 drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist.

Otc - Ask Doctor Section


Ask a doctor before use if you have

â–  liver disease

â–  heart disease

â–  high blood pressure

â–  thyroid disease

â–  diabetes

â–  trouble urinating due to an enlarged prostate gland

â–  persistent or chronic cough such as occurs with smoking, asthma, or emphysema

â–  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 exceed recommended dosage.

Otc - Stop Use Section


Stop use and ask a doctor if

â–  nervousness, dizziness, or sleeplessness occur

â–  pain gets worse or lasts for more than 7 days

â–  fever gets worse or lasts more than 3 days

â–  redness or swelling is present

â–  new symptoms occur

â–  cough comes back or occurs with 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. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Taking more than the recommended dose (overdose) may cause liver damage. 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 Warnings)

Adults and children: (12 years and over)

â–  take 2 caplets every 4 hours

â–  do not take more than 12 caplets in 24 hours

Children under 12 years: do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage.

Other Safety Information


Other information

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

â–  tamper evident sealed packets

â–  do not use any opened or torn packets

Inactive Ingredient Section


Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Otc - Questions Section


Questions or comments? 1-800-634-7680

Package Label.principal Display Panel


Medique®

Cold & Cough Product

Multi-Symptom Relief

Pull to Open

Pain Reliever/Fever Reducer • Acetaminophen 325 mg

Cough Suppressant • Dextromethorphan HBr 10 mg

Nasal Decongestant • Phenylephrine HCl 5 mg

80 Caplets

(40 x 2)

Tamper Evident Unit Dose Packets



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"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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