Giltuss Allergy Plus Cough & Congestion
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 10 mL)
Chlorpheniramine maleate, USP 4 mg
Dextromethorphan HBr, USP 20 mg
Phenylephrine HCl, USP 10 mg
OTC - PURPOSE SECTION
Purposes
Antihistamine
Cough suppressant
Nasal decongestant
INDICATIONS & USAGE SECTION
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 SECTION
Warnings
OTC - DO NOT USE SECTION
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 SECTION
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 SECTION
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 SECTION
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 SECTION
Stop use and ask a doctor if
These could be signs of a serious condition.
- 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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of overdose, seek professional help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
| 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 |
- 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
STORAGE AND HANDLING SECTION
Other information
- store at room temperature 15° - 30°C (59° - 86°F)
- close cap tightly
- SAVE CARTON FOR COMPLETE DRUG FACTS
INACTIVE INGREDIENT SECTION
Inactive ingredients
citric acid, flavor, glycerin, methylparaben, propylparaben, purified water and sucralose
OTC - QUESTIONS SECTION
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.
SPL UNCLASSIFIED SECTION
Tamper evident: do not use if safety seal is broken or missing
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
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
TUTTI FRUTTI FLAVOR
4FL OZ (118 mL)
- SNEEZING
- RUNNY NOSE
- ITCHY AND WATERY EYES
- COUGH
- STUFFY NOSE
- SINUS PRESSURE