Conrx Nighttime
FDA Label NDC 68737-239

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eagle Distributors,inc. for the product Conrx Nighttime (NDC 68737-239). 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 other, otc - purpose, uses, liver warning, sore throat warning, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients (in each Caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Dexylamine succinate 6.25 mgAntihistamine

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Liver Warning

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

  • more than 4 doses in 24 hrs, 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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure wheather a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking 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.
  • to make a child sleep

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

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking sedatives or tranquilizers.
  • taking the blood thinning drug warfarin

When Using This Product

  • do not use more than directed
  • 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, and tranquilizers may increase drowsiness

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
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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 & for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed - see Overdose warning
  • do no exceed 4 doses per 24 hours

    • adult and children 12 years and over, 2 Caplets with water every 6 hours
    children 4 to under 12 years, ask a doctor
    children under 4 years, do not use

Other Information

  • store at room temperature

Inactive Ingredients

cross carmellose sodium, D&C Yellow No.10, FD&C Blue No.1, cellulose microcrystalline, polysorbate 80, silicone dioxide, talc, titanium dioxide, corn starch, gelatin, magnesium stearate, sodium starch glycolate, sodium benzoate, hydroxy propyl methyl

Questions?

1-855-619-7900

Principal Display Panel - 50 X 2 Caplet Pouch Box

Compare to the Active Ingredients in
NyQuil®

ConRx® NightTime
COLD & FLU
NightTime Relief

Acetaminophen, Doxylamine Succinate, Dextromethorphan HBr

  • ⋆Aches, Fever & Sore Throat
  • ⋆Sneezing, Runny Nose
  • ⋆Cough

    • 2 Caplets Each Pouch

    TO OPEN
    PUSH IN TAB AND PULL OUT

    Compare to the Active Ingredients in
    NyQuil®

    2 Caplets Each Pouch

    Principal Display Panel (50 x 2 Caplet Pouch Box)

    Principal Display Panel (50 x 2 Caplet Pouch Box)

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