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Severe Cold Relief (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. Target Corporation

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl and guaifenesin

Severe Cold Relief tablet, film coated - (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) image
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IMPRINT: 44 503     SHAPE: capsule
    COLOR: yellow

All Imprints

{8 (acetaminophen 325 mg / chlorpheniramine maleate 2 mg / dextromethorphan hydrobromide 10 mg / phenylephrine hydrochloride 5 mg oral tablet) / 16 (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochlor - 44 503 oval yellow

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestion

Uses


  • temporarily relieves these common cold/flu symptoms:

    • headache

    • minor aches and pains

    • sore throat

    • nasal congestion

    • cough

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs  more productive

  • temporarily reduces fever

Warnings


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

  • diabetes

  • heart disease

  • 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)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage

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

  • new symptoms occur

  • fever gets worse or lasts more than 3 days

  • redness or swelling is present

  • 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.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions


  • do not take more than directed (see overdose warning)

  • adults and children 12 years and over

    • take 2 caplets every 4 hours

    • swallow whole - do not crush, chew, or dissolve

    • 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 Information


  • store at controlled room temperature 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive Ingredients


corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Principal Display Panel


NDC 11673-503-08

severe cold relief

non-drowsy

acetaminophen, 325 mg

dextromethorphan HBr, 10 mg

guaifenesin, 200 mg

phenylephrine HCl, 5 mg

Compare to active ingredients

in Tylenol® Cold Multi-Symptom

Severe Daytime Caplets

pain reliever, fever reducer, nasal decongestant, cough suppressant, expectorant

for ages 12 and older, with cool-blast sensation

up to 4 hours relief

does not contain pseudoephedrine

up & up™

DAY

24 CAPLETS

24 CAPLETS SHOWN ACTUAL SIZE ABOVE

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

50844        REV0111B50308

094 14 0202 ID201455

Distributed by Target Corporation, Mpls., MN 55403

© 2012 Target Brands, Inc.

All Rights Reserved   Shop Target.com
Target 44-503C

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."

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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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