Gencare Daytime Cold And Flu Softgel Capsule, Liquid Filled
FDA Label NDC 72090-062

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Gencare Daytime Cold And Flu Softgel (NDC 72090-062). 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 drug facts, active ingredients (in each softgel), purpose, uses:, warning, do not use:, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (In Each Softgel)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

Acetaminophen 325mg.....................Pain reliever/fever reducer
Dextromethorphan HBr 10mg..................... Cough suppressant
Phenylephrine HCl 5mg ............................. Nasal decongestant

Uses:

temporarily relieves common cold/flu symptoms:
■ nasal congestion

■ cough due to minor throat & bronchial irritation

■ sore throat

■ headache

■ minor aches & pains

■ fever

Warning

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

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash.

If a skin reaction occurs, stop use and seek medical help right away

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 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.

Directions

■ take only as directed

■ do not exceed 4 doses per 24 hrs. 

 Adults and children 12 yrs and overtake 2 softgels with water every 4 hrs. 
 Children 4 to under 12 yrs  ask a doctor
 Children under 4 yrs do not use

Other Information

■ store at room temperature

Inactive Ingredients

Polyethylene glycol 400, propylene glycol, povidone K30, purified water, gelatin, glycerin, sorbitol sorbitan solution, FD&C red#40, FD&C yellow #6.

* Please review the disclaimer below.