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Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, 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: 812     SHAPE: oval
    COLOR: green

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Drug Facts


Active Ingredients (in Each Softgel)


Acetaminophen 325 mgDextromethorphan HBr 10 mgDoxylamine succinate 6.25 mgPhenylephrine HCl 5 mg

Purposes


Pain reliever/fever reducerCough suppressantAntihistamineNasal 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  • rashIf 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.

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.

Ask a doctor before use if you have  • liver disease  • heart disease  • high blood pressure  • thyroid disease  • diabetes  • glaucoma  • a sodium-restricted diet  • trouble urinating due to enlarged prostate gland  • 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

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

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

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.

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: In case of overdose, get medical help or contact a Poison Control Center right away.

Directions


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

Other Information


• store at 20-25°C (68-77°F)   • protect from light, heat and moisture

Inactive Ingredients


edible printing ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments?


Call 1-888-577-8033 Monday - Friday 8am - 4pm EST


COMPARE TO VICKS® NYQUIL® SEVERE COLD & FLU ACTIVE INGREDIENTS*

MULTI-SYMPTOM RELIEF

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademarks Vicks® and NyQuil™.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Distributed by:Strive Pharmaceuticals Inc.East Brunswick, NJ 08816

Product of United Arab Emirates

Packaging




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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