Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
FDA Label NDC 55629-012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride (NDC 55629-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each capsule), purose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purose

  • Pain reliever/ fever reducer
  • Cough suppressant
  • Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • nasal congestion
  • sore throat
  • headache
  • minor aches/pains
  • fever

Warnings

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • with other medicines containing acetaminophen
  • 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

  • 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

Stop Use And Ask A Doctor If

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.

Directions

  • take only as recommended - see OVERDOSE warning
  • do not exceed 6 doses per 24 hours
    • Adults and children 12 years of age and older2 LiquiCaps with water every 4 hours
    Children under 12 years of ageask doctor

    When using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

Other Information

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

Inactive Ingredients

polyethylene glycol 400, propylene glycol, povidone k30, fd&c red no. 40, fd&c yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water

Principal Display Panel - Shipping Label

Acetaminophen, Dextromethorphan HBr Phenylephrine HCL capsules

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

LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-012-
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 WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.

* Please review the disclaimer below.