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Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Headache Sleep Initiation and Maintenance Disorders Rhinitis, Allergic, Perennial


IMPRINT: SD26     SHAPE: oval
    COLOR: green

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Drug Facts

Active Ingredient (in Each Softgel)


Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Purpose


Pain reliever/fever reducer Cough suppressant Antihistamine

Uses


temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache• minor aches & pains• fever• runny nose & sneezing

Warnings


Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 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 •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 n 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, & tranquilizers may increase drowsiness

Otc - Stop Use Section


Stop use and ask a doctor if • pain 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 • 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 (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions


• take only as directed • do not exceed 8 softgels per 24 hrs • adults & children 12 yrs & over 2 Softgels with water every 6 hrs • children 4 to under 12 yrs ask a doctor • children under 4 yrs do not use

Other Information


• store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.

Questions Or Comments?


1-800-373-6981 (toll-free)

Inactive Ingredients


butylated hydroxyanisole, FD&C Blue No. 1, gelatin, glycerin, methyl paraben, polyethylene glycol-400, propylene glycol, propyl Paraben, povidone, purified water, sorbitol


Distributed by: Shield Pharmaceuticals Corp. Hauppauge, NY 11788

Principal Display Panel


ValuRx

Compare to the Active Ingredients in Vicks® NyQuil® Cold & Flu LiquiCaps Nighttime Cold & Flu Multi-Symptom Relief Acetaminophen Dextromethorphan HBr Doxylamine succinate

• Headache, Fever, Sore Throat, • Minor Aches & Pain • Sneezing, Runny Nose • Cough

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"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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