FDA Label for Giltuss D
View Indications, Usage & Precautions
Giltuss D Product Label
The following document was submitted to the FDA by the labeler of this product Gil Pharmaceutical Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredients (in each 10 mL) Purpose
Chlorpheniramine maleate 3.5 mg .... Antihistamine
Phenylephrine HCl 10 mg ................ 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
- to sedate a child or to make a child sleepy
- 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.
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- taking sedatives or tranquilizers
- 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
- excitability may occur, especially in children
Ask a doctor or pharmacist before use if you are
When using this product
Otc - When Using
Otc - Stop Use
Stop use and ask a doctor if
- You get nervous, dizzy, or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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
- not take more than 6 doses in any 24-hour period
- use enclosed dosing cup
- keep dosage cup for use with this product
- mL = milliliter
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 |
Storage And Handling
Other information
- store at room temperature 15°-30°C (59°-86°F)
- close cap tightly
- SAVE CARTON FOR COMPLETE DRUG FACTS
Inactive Ingredient
Inactive ingredients
Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sodium Carboxymethylcellulose, Sucralose.
Otc - Questions
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.
Label revised: 04/24
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
Principal Display Panel
Giltuss-D ALLERGY & CONGESTION - NDC 58552-147-04 - Bottle Label
Giltuss-D ALLERGY & CONGESTION - NDC 58552-147-04 - Carton Label
* Please review the disclaimer below.
