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Drug Facts
Giltuss Allergy Plus Tablet
FDA Label NDC 58552-334
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 Allergy Plus (NDC 58552-334). 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)
Chlophedianol HCl 24 mg
Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCl 10 mg
Otc - Purpose
Purposes
Cough Suppressant
Antihistamine
Nasal Decongestant
Indications & Usage
Uses
Temporarily relieves runny nose, sneezing, and itchy and watery eyes due to hay fever or other upper respiratory allergies. Temporarily relieves nasal congestion due to the common cold. Temporarily controls cough due to minor bronchial irritation occurring with the common cold.
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
- persistent or chronic cough such as occurs with smoking, asthma
- chronic bronchitis, or emphysema
- excessive phlegm (mucus)
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
- cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache
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. 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 6-8 hours. Do not take more than 4 tablets in a 24-hour period.
- Children 6 to 12 years of age: Take 1/2 tablet every 6-8 hours. Do not take more than 2 tablets in a 24-hour period.
- Children under 6 years: Consult a physician.
Storage And Handling
Other information
- store at room temperature, USP
- do not use if pouch is open or torn
Inactive Ingredient
Inactive Ingredients
Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Silica.
Otc - Questions
Questions? Call 787-848-9114
Package Label.Principal Display Panel
MAXIMUM STRENGTH
Giltuss® ALLERGY PLUS
COUGH & CONGESTION
20 TABLETS
SUGAR FREE. DYE FREE. PRESERVATIVE FREE.
Relieves
- Sneezing
- Runny Nose
- Itchy & watery eyes
- Double acting cough supressant
- Stuffy Nose
- Sinus Pressure
* Please review the disclaimer below.
