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  5. Label Information: Acetaminophen Dextromethorphan Hydrobromide And Phenylephrine Hydrochloride

FDA Label for Acetaminophen Dextromethorphan Hydrobromide And Phenylephrine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    5. SORE THROAT WARNING
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSE WARNING
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS OR COMMENTS?
    18. PRINCIPAL DISPLAY PANEL - 10 CAPSULE BLISTER PACK CARTON

Acetaminophen Dextromethorphan Hydrobromide And Phenylephrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product J.p. Business Enterprise. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed By: J.P Business Enterprise
Lake Grove, NY 11755


Otc - Purpose



Active ingredients (in each softgel)Purpose
Acetaminophen 325 mg, USPPain reliever/fever reducer
Dextromethorphan Hydrobromide 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses



temporarily relieves common cold/flu symptoms:

  • minor aches
  • pains
  • sore throat
  • fever
  • muscular aches
  • headaches
  • nasal congestion
  • cough

Liver Warning



This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4 doses 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking the blood-thinning drug Warfarin.


When Using This Product



  • do not use more than directed.

Stop Use And Ask A Doctor If



  • you get nervous, dizzy, or sleepless
  • symptoms get worse or last 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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose Warning



Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children, even if you do not notice any signs or symptoms.


Directions



  • Take only as directed—see Overdose warning.
  • do not exceed 4 doses per 24 hours.
    • adults and children 12 years of age and overswallow 2 softgels with water
    children 4 to under 12 years of ageask a doctor
    children under 4 years of agedo not use

    If taking Daytime and Nighttime softgels carefully read each label to insure correct dosing


Other Information



  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • this product does not contain phenylpropanolamine

Inactive Ingredients



FD&C Yellow No. 6, FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide


Questions Or Comments?



1-888-333-9792


Principal Display Panel - 10 Capsule Blister Pack Carton



VALUMEDS

SEE NEW WARNINGS INFORMATION

Compare to the active ingredients
in VICKS® DAYQUIL®*

NON-DROWSY
DAY TIME

COLD & FLU MULTI-SYMPTOM RELIEF

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHERNE HCl

* Please review the disclaimer below.