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Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate Dailymed

  1. Human OTC
  2. Uncompetitive N-methyl-D-aspartate Receptor Antagonist
  3. ONE2ZEE LIMITED LIABILITY COMPANY

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl, 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 Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Doxylamine Succinate solution - image

  1. FDA Adverse Reactions

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Active Ingredients (in Each Capsule)


Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine Hydrochloride 5 mg

Doxylamine Succinate 6.25 mg

Purpose


Pain reliever/ fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves common cold/flu symptoms:

    ο nasal congestion    ο sinus congestion & pressure    ο cough due to minor throat & bronchial irritation    ο minor aches & pains    ο headache    ο fever    ο sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warning


Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 10 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

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 to sedate children.

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • in children under 12 years of age

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough with excessive phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

  • do not exceed recommended dosage
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Direction

  • take only as directed - see Overdose warning
  • do not exceed 4 doses per 24 hours
adults & children 12 years of age and over 2 softgels with water every 4 hours
Children under 12 years of age ask a doctor

When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Other Information:

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

Inactive Ingredients


polyethylene glycol 400, propylene glycol, povidone k30, sodium hydroxide, FD&C blue #1, D&C yellow #10, titanium dioxide, gelatin, glycerin, sorbitol, water

Principal Display Panel - Shipping Label


Acetaminophen, Dextromethorphan HBr, Phenylephrine HCL, Doxylamine Succinate capsules

Each Softgel Contains:(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Phenylephrine Hydrochloride USP 5mg, Doxylamine Succinate 6.25 mg)

LOT NO:DRUM NO:MFG DATE:QUANTITY:NDC NO: 55629-016-EXP DATE:

WARNING:KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITHTHE F.D & C.ACT AND REGULATIONS THEREUNDER.



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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