FDA Label for Giltuss Allergy Plus Cough And Congestion
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Giltuss Allergy Plus Cough And Congestion 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.
Other
Drug Facts
Tamper evident: do not use if safety seal is broken or missing
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
Otc - Active Ingredient
Active ingredients (in each 10 mL)
Chlorpheniramine maleate, USP 4 mg
Dextromethorphan HBr, USP 20 mg
Phenylephrine HCl, USP 10 mg
Otc - Purpose
Purposes
Antihistamine
Cough suppressant
Nasal decongestant
Indications & Usage
Uses
- temporarily relieves
- cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
- nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily restores freer breathing through the nose
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.
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlargement of the prostate gland
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking any other oral nasal decongestant or stimulant
Otc - When Using
When using this product
- do not use more than directed
- may cause marked drowsiness
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness effect
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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 a fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, seek professional help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Do not take more than 6 doses in any 24-hour period
- use enclosed dosing cup
- keep dosage cup for use with this product
- mL=milliter
adults and children 12 years and over | 10 mL every 4 to 6 hours |
children 6 to under 12 years | 5 mL every 4 to 6 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, propylparaben, purified water and 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.
Package Label.Principal Display Panel
MAXIMUM STRENGTH
Giltuss® ALLERGY PLUS COUGH & CONGESTION
ANTIHISTAMINIC, ANTITUSSIVE, & NASAL DECONGESTANT
ALCOHOL FREE. SODIUM FREE. SUGAR FREE. DYE FREE.
RELIEVES
- SNEEZING
- RUNNY NOSE
- ITCHY AND WATERY EYES
- COUGH
- STUFFY NOSE
- SINUS PRESSURE
TUTTI FRUTTI FLAVOR
4FL OZ (118 mL)
* Please review the disclaimer below.