The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories Inc. for the product Giltuss D (NDC 65852-010). 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 purposes, warnings, ask a doctor, ask a doctor or pharmacist, when using, pregnancy or breast-feeding, stop use section, otc - active ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Purposes
Antihistamine
Nasal decongestant
Uses
Temporary relieves these symptons due to hay fever ( allergy rhinitis) or other respiratory allergies:
runny nose, sneezing, itchy, watery eyes, nasal congestion, itching of nose or throat, sinus congestion and pressure
Warnings:
Do not use to sedate a child or to make a child sleepy, if you ar etaking a prescription monoamine oxidase inhibitor ( MAOI) ( certains 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 desease, high blood pressure, thyroid desease, diabetes, trouble urinating due to enlarged prostate gland, glaucoma, a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or ephysema
Ask a doctor or pharmacist before use if you are, taking sedatives or tranquilizers
When using this product, do not use more than directed, may cause drowsiness, avoid alcoholic beverages, alcohol, sedatives, and tranquilizers may increase drowsiness, avoid alcoholic drinks, be careful when driving a motor vehicle or operating machinery, exitability may occur, especially in children.
If Pregnancy or breast-feeding, ask a health professional before use. Keep out of reach of children. In case or overdose, get medical help or contact a Poisson Control Center right away ( 1-800-222-1222)
Stop use and ask a doctor if, if you get nervous, dizzy or sleepless, symptons do not get better witi
hin 7 days or are accompanied by fever
Chlorpheniramine maleate 3.5 mg
Phenilephryne HCl, 10 mg
Directions, not take more than 6 doses in any 24 hours period, use enclosed dosing cup, keep dosage cup for use with this product, ml= mililiter
Adults and children 12 years and over 10 ml every 4 hours
Children 6 to under 12 years 5 ml every 4 hours
Children under 6 years Consult a doctor
Other information store at room temperature 15 - 30 oC (59-86 o F), close cap tightly, save carton for complete drug facts
Inactive Ingredients
Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified water, Sodium Carboxymethylcellulose, Sucralose.
Call 1-787-848-9114 Monday-Friday 9AM-5PM EST, Call your doctor for medical advice in the event of side effects
Indication and usage section
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= mililiter
Adults and children 12 years and over 10 ml every 4 hours
Children 6 to under 12 years 5 ml every 4 hours
Children under 6 years Consult a doctor
Keep out of reach of children.
In case or overdose, get medical help or contact a Poison Control Center right away ( 1-800-222-1222)
Giltuss D
Allergy & Congestion
Dye Free, preservative free, sodium free, sugar free
Sneezing, Runny Nose, Itchy & Water eyes, Itchy Throat or Nose, Sinus pressure, stuffy nose
Tutti Frutti Flavor
$ floz 118 ml
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