The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories Inc. for the product Giltuss Allergy Plus (NDC 65852-017). 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, uses, warnings, ask a doctor, ak a doctor or pharmacist before use it, stop use and ask a doctor if, if pregnant or breast-feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each 10 m) Purposes
Chlorpheniramine maleate, USP 4 mg -------------------------------Antihistamine
Dextromethorphan HBr, USP 20 mg -----------------------------------Cough supressant
Phenylephrine HCl, USP 10 mg -----------------------------------------Nasal descongestant
Uses
Temporary relieves:
Cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, helps loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive, temporary relieves nasal congestion due to a cold
Warnings
Do not use
If your child is 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 don’t know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have:
heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to an enlarged prostate unless directed by a doctor, a cough with too much phlegm (mucus), a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
As a doctor or pharmacist before use if you ar etaking any other oral nasal descongestant or stimulant, sedatives, tranquilizer, and drugs used for depression, especially momoamine oxidase inhibitors ( MAOI)
Stop use and ask a doctor if
if you get nervous, dizzy, or sleepless, symptoms do not get better within 7 days or are accompanied by fever, cough lasts more than 7 days, comeback, or is accompanied by fever,rash, or persistent headache
These could be signs of a serious condition.
If pregnant or breast- feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately
Directions
Do not take more than 6 doses in any 24 hours period
use enclosed dosing cup
Keep dosage cup for use with this product
ml= milliliters
Adults and children 12 years & over 10 ml every 4 to 6 hours
Children 6 to under 12 years of age 5 ml every 4 to 6 hours
Children under 6 years of age Consult a doctor
hildren under 6 years of age Consult a doctor
Other information
Store at room temperature 15-30 °C (59° -86 ° F)
Close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS
Inactive Ingredients
Citric Acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose
Questions or comments?
Call 1-787-848-9114, Monday-Friday 9AM – 5PM EST
Call your doctor for medical advice in the event of side effects.
Do not take more than 6 doses in any 24 hours period
use enclosed dosing cup
Keep dosage cup for use with this product
ml= milliliters
Adults and children 12 years & over 10 ml every 4 to 6 hours
Children 6 to under 12 years of age 5 ml every 4 to 6 hours
Children under 6 years of age Consult a doctor
keep out of reach of children section
. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately
Maximum strength
Giltuss Allergy Plus
Cough & Congestion
Alcohol free, Sodium free, sugar free, dye free
Sneezing, runny nose, itchy and watery eyes, cough, stuffy nose, sinus pressure
Tutti Frutti flavor
4 floz 118 ml
* Please review the disclaimer below.
