FDA Label for Giltuss Childrens Cough And Chest Congestion
View Indications, Usage & Precautions
Giltuss Childrens Cough And Chest 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
Other information
- store at room temperature 15°- 30°C (59° - 86°F)
- close cap tightly
- SAVE CARTON FOR COMPLETE DRUG FACTS
Tamper evident: do not use if safety seal is broken or missing
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
Otc - Active Ingredient
Active ingredients (in each 5 mL)
Dextromethorphan HBr, 10 mg
Guaifenesin, 100 mg
Otc - Purpose
Purposes
Cough Suppressant
Expectorant
Indications & Usage
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 to help your child get to sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes
Otc - Do Not Use
Do not use if your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if the child has
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts such as occurs with asthma
Otc - Stop Use
Stop use and ask a doctor or pharmacist if the child has
- symptoms do not get better within 7 days or are accompanied by fever
- cough comes back, or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
Otc - When Using
When using this product
- do not use more than directed.
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.
Dosage & Administration
Directions
- do not take more than 6 doses in any 24 hour period
- use enclosed dosing cup
- keep dosing cup for use with this product
- mL = milliliters
| children under 2 years | Consult a doctor |
| children 2 to under 6 years of age | 2.5 mL every 4 hours |
| children 6 to under 12 years of age | 5 mL every 4 hours |
| children 12 years and over | 10 mL every 4 hours |
Inactive Ingredient
Inactive ingredients Citric acid, flavor, D&C red #33, flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose
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
Children's
GILTUSS®
COUGH & CHEST CONGESTION
ANTITUSSIVE AND EXPECTORANT
Non-Drowsy. Alcohol Free
- COUGH AND COLD
- CHEST CONGESTION
- LIQUIFIES AND LOOSENS PHLEGM AND MUCUS
RASPBERRY FLAVOR
4FL OZ (118 mL)
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