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Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Headache Sleep Initiation and Maintenance Disorders Rhinitis, Allergic, Perennial Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular


IMPRINT: 116 A07     SHAPE: oval
    COLOR: green

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Drug Facts


Active Ingredients (in Each Softgel)


Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Purpose


Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses


temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage

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 every day 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 • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema • trouble urinating due to enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION


Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin

OTC - WHEN USING SECTION


When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur n avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness

OTC - STOP USE SECTION


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 n fever gets worse or lasts more than 3 days n 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.

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 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.

Directions

  • take only as directed
  • ndo not exceed 8 softgels per 24 hour
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

Other Information


• do not exceed 25°C (77°F)

Inactive Ingredients


D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, sodium hydroxide*, titanium dioxide * may contain this ingredient

Questions Or Comments?


1-888-333-9792

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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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