The following Structured Product Label (SPL) was submitted to the FDA by Dextrum Laboratories, Inc for the product Giltuss Honey Cough And Chest Congestion (NDC 65852-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indication and user panel, active ingredient, otc - purpose, warnings, keep out of the reach of the children, pregnant or breast feedings, dosage and administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Indication and user section:
Do not take more than 6 doses in any 24-hours perio. use enclosed dosing cup
Adults and childrens 12 years and over 10ml every 4 hours
Children 6 to 12 years of age 5 ml every 4 hours
Children 4 to under 6 years of age 2.5ml every 4 hous
Children under 4 yeras of age Consult a doctor
Acive Ingredient
In each 10 ml
Dextromethorphan HBr 20mg
Guafenesin 200mg
Purposes:
Sough suppresant
Expectorant
Warnings
Do not use if you are now taking a prescription monoamine oxidase inhibidor (MAOI) (Certain drugs for depression, psychiatric or emotional conditions, or Parkinson's desease), or for two weeks after stopping the MAOI drug. If you do not know if you prescription drug constains an MAOI, ask a doctor or pharmacist before taking this product.
Warnings:
Do not use if you are now taking a prescription monoamine oxidase inhibidor (MAOI) (Certain drugs for depression, psychiatric or emotional conditions, or Parkinson's desease), or for two weeks after stopping the MAOI drug. If you do not know if you prescription drug constains an MAOI, ask a doctor or pharmacist before taking this product.
Keep out of the reach of the children:
In case of overdose, get medical help or contact a poison Control Center right away.
If pregnant or breast-feeding, ask a health professioinal before use.
Dosage
Adults and childrens 12 years and over 10ml every 4 hours
Children 6 to 12 years of age 5 ml every 4 hours
Children 4 to under 6 years of age 2.5ml every 4 hous
Children under 4 yeras of age Consult a doctor
Inacyive ingredients
C arboxymethylcellulose sodium, citric acid, glycerin, natural and artificial flavor, , natural grade A honey, methylparaben, propylene glycol,
propylparaben, purified water, sucralose.
Questions or comments
Call 787-848-9114 Monday-Friday 9AM-5PM EST.
Call your doctor for medical advice in the event of side effects.
Maximum strength. Maxima Concentracion
Alcohol Free
Dye free
Non-Drowsy
True source
Certified Honey
Giltuss Honey Cough % Chest Congestion
Tos y congestion de Pecho
cough and cold, chest Tos y catarro,
Congestion, liquifies Congestion de Pecho,
and loosens phlegm and mucus Licua y suelt LA FLEMA Y EL MOCO
Honey Lemon flavor. Sabor a Miel y limon 4FL OZ (118ml)
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