Label: CHILDRENS GILTUSS D syrup
- NDC Code(s): 58552-148-04
- Packager: Gil Pharmaceutical Corp
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 12, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Do not use
- to sedate a child or to make a child sleepy
- if the child 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if the child is
- taking sedatives or tranquilizers
When using this product
- do not use more than directed
- may cause drowsiness
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- if the child gets nervous, dizzy, or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
-
DOSAGE & ADMINISTRATION
Directions
- not take more than 6 doses in any 24-hour period
- use enclosed dosing cup
- keep dosage cup for use with this product
- mL = milliliter
Children under 6 years of age
Consult a Doctor
children 6 to under 12 years of age
5 mL every 4 hours
Adults and children 12 years and over
10 mL every 4 hours
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS GILTUSS D
childrens giltuss d syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-148 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1.75 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID ACETATE (UNII: DSO12WL7AU) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor TUTTI FRUTTI Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58552-148-04 1 in 1 CARTON 04/11/2024 1 1 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/11/2024 Labeler - Gil Pharmaceutical Corp (176826592)
