Other
Drug Facts
MANUFACTURED FOR GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
Giltuss D Allergy And Congestion Tablet
FDA Label NDC 58552-333
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gil Pharmaceutical Corp for the product Giltuss D Allergy And Congestion (NDC 58552-333). 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 - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients (in each tablet)
Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCl 10 mg
Otc - Purpose
Purposes
Antihistamine
Nasal Decongestant
Indications & Usage
Uses
Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- nasal congestion
- itching of the nose or throat
- sinus congestion and pressure
Warnings
Warnings
Otc - Do Not Use
Do not use 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.
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product
- do not exceed recommended dose
- excitability may occur, especially in children
- drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Otc - Stop Use
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not improve within 7 days or occur with a fever
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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Dosage & Administration
Directions
adults and children 12 years and over
- take 1 tablet every 4 hours
- do not take more than 6 tablets in 24 hours
- children 6 to under 12 years of age: take 1/2 tablet every 4 hours, not to exceed 3 tablets in a 24 hour period
- do not use this product for children under 6 years of age
Storage And Handling
Other information
- store at room temperature, USP
- do not use if blister seal is broken
Inactive Ingredient
Inactive ingredients
Magnesium Stearate, Microcrystalline Cellulose and Silica.
Otc - Questions
Questions? Call 787-848-9114
Package Label.Principal Display Panel
MAXIMUM STRENGTH
NO PSEUDOEPHEDRINE
Giltuss®-D
ALLERGY & CONGESTION
20 TABLETS
SUGAR FREE. ALCOHOL FREE. DYE FREE. SODIUM FREE
RELIEVES
- SNEEZING
- RUNNY NOSE
- ITCHY, WATERY EYES
- ITCHY THROAT OR NOSE
- SINUS PRESSURE
- STUFFY NOSE
* Please review the disclaimer below.
