Conrx Sinus
FDA Label NDC 68737-236

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 Sinus (NDC 68737-236). 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 ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Tablet)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel - 2 Caplets × 50 Pouch Box

Active Ingredient (In Each Tablet)

Acetaminophen 325mg

Guaifenesin 200mg

Phenylephrine HCl 5mg

Purpose

Pain reliever/ fever reducer

Expectorant

Nasal decongestant

Uses

Uses For the temporary relief of: sinus congestion and pressure, headache, nasal congestion, minor aches and pains, helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive, temporarily relieves nasal congestion due to the common cold, and hay fever and other upper respiratory allergies.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets 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

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

Ask A Doctor Before Use If You Have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
a persistent 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

Stop Use And Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion or cough gets worse or lasts for more than 7 days
fever gets 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 serious conditions.

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

In case of overdose, get medical help or contact a Poison Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and Children 12 years and over	Take 1-2 tablets every 4 hours as needed Do not taking more than 8 tablets in 24 hour
Children under 12 years of age	Consult a doctor

Other Information

Do not use if pouch is torn or damaged.
Store between 15-30°C (59-86°F). Avoid excessive heat and humidity.
See side panel for lot number and expiration date.

Inactive Ingredients

Colloidal silicon dioxide, Sodium Lauryl Sulphate, Edetaet disodium, dioctyl sodium sulphosuccinate, polyvinyl pyrollidone, gelatin, corn starch', magnesium Stearate, microcrystalline cellulose, polyethylene glycol 6000,Sodium Benzoate ,Sodium Starch Glycolate, Stearic acid, Purified Talc, Titanium Dioxide.