Guaifenesin STRAWBERRY-BANANA FLAVOR
1006906e-d6d7-4f49-92bf-3cb2d2cdbb16
HUMAN OTC DRUG LABEL
Jun 18, 2025
Innovida Pharmaeutique Corporation
DUNS: 080892908
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GUAIFENESIN
PRODUCT DETAILS
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product label
INDICATIONS & USAGE SECTION
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
DOSAGE & ADMINISTRATION SECTION
Directions
- Do not take more than 6 doses in any 24 hours period
|
age |
dose |
|
Adults and Children 12 years of age and over: Children under 12 years of age: |
Take 2-4 teaspoonful (5mL) every 4 hours Consult a physician |
SPL UNCLASSIFIED SECTION
Questions or Comments? 1-888-462-4166
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Citric acid, FD&C yellow #5, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry- banana flavor, sucralose.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Guaifenesin,USP 100 mg (in each 5ml tsp)
OTC - PURPOSE SECTION
Purpose
Expectorant
WARNINGS SECTION
Warnings
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Stop use and ask a doctor if■ cough persists for more than a week, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a doctor. A persistent cough may be a sign of a serious condition.
If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.