Giltuss Children's Cough & Cold
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 2.5 mL)
Dextromethorphan HBr 7.5 mg
Guaifenesin 150 mg
Phenylephrine HCI 5 mg
OTC - PURPOSE SECTION
Purposes
Cough Suppressant
Expectorant
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves
- cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough
- helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes
- stuffy nose
Warnings
OTC - DO NOT USE SECTION
Do not use
- to sedate a child or make a child sleepy
- in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts such as occurs with asthma or chronic bronchitis
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the child is
- taking any other oral nasal decongestant or stimulant
- taking sedatives, tranquilizers
OTC - STOP USE SECTION
These can be signs of a serious condition.
- Stop use and ask a doctor if
- nervousness, dizziness, or sleepless occurs
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back, or occurs with fever, rash or persistant headache
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
| children under 2 years | Consult a doctor |
| children 2 to under 6 years of age | 1.25 mL every 4 hours |
| children 6 to 12 years of age | 2.5 mL every 4 hours |
| children 12 years and over | 5 mL every 4 hours |
- do not exceed recommended dosage
- do not take more than 6 doses in any 24 hour period
- keep dosing cup for use with this product
- mL = milliliters
SPL UNCLASSIFIED SECTION
Other information
- store at room temperature 15°- 30°C (59° - 86°F)
- close cap tightlly
- SAVE CARTON FOR COMPLETE DRUG FACTS
INACTIVE INGREDIENT SECTION
Inactive ingredients
citric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, 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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Children's
GILTUSS®
COUGH & COLD
ANTITUSSIVE, EXPECTORANT, NASAL DECONGESTANT
Alcohol Free. Sugar Free. Dye Free.
CHERRY FLAVOR
4 FL OZ (118 mL)
- COUGH AND COLD
- CHEST CONGESTION
- STUFFY NOSE
- NASAL CONGESTION
- LOOSEN PHLEGM AND MUCUS
- SINUS PRESSURE