FDA Label for Childrens Giltuss Honey Dm Cough
View Indications, Usage & Precautions
Childrens Giltuss Honey Dm Cough 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 ingredient (in each 5 mL)
Dextromethorphan HBr, 15 mg
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
Warnings
Warnings
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 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 persistent or chronic cough such as occurs with asthma
Otc - Stop Use
Stop use and ask a doctor if the child has a cough that lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
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 4 doses in any 24-hour period
- use enclosed dosing cup
- keep dosage cup for use with this product
- ml = milliliters
children under 4 years | Consult a doctor |
children 4 to under 6 years | 2.5 mL every 6-8 hours |
children 6 to under 12 years | 5 mL every 6-8 hours |
children 12 years and over | 10 mL every 6-8 hours |
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 natural and artificial flavor, natural grade A honey, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, 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
Children 4-12
Children's Giltuss®
Honey DM Cough
Alcohol Free. Dye Free. Non Drowsy.
PERSISTENT COUGH UP TO 8 HOURS
Made with real honey
HONEY LEMON FLAVOR.
4FL OZ (118 mL)
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