Giltuss-d
298f5457-a7df-474d-9854-68918ee3d330
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each 10 mL) Purpose Chlorpheniramine maleate 3.5 mg .... Antihistamine Phenylephrine HCl 10 mg ................ Nasal decongestant
Medication Information
Warnings and Precautions
Warnings
Indications and Usage
Uses
Temporarily relieves these Symptoms due to hay fever (allergic rhinitis) or other upper-respiratory allergies:
- runny nose
- Sneezing
- Itchy, watery eyes
- nasal congestion
- itching of the nose or throat
- sinus congestion and pressure
Dosage and 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
|
Adults and children 12 years and over |
10 mL every 4 hours |
|
Children 6 to under 12 years |
5 mL every 4 hours |
|
Children under 6 years |
Consult a doctor |
Description
Active ingredients (in each 10 mL) Purpose Chlorpheniramine maleate 3.5 mg .... Antihistamine Phenylephrine HCl 10 mg ................ Nasal decongestant
Section 44425-7
Other information
- store at room temperature 15°-30°C (59°-86°F)
- close cap tightly
- SAVE CARTON FOR COMPLETE DRUG FACTS
Section 50566-9
Stop use and ask a doctor if
- You get nervous, dizzy, or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
Section 50567-7
Section 50570-1
Do not use
- to sedate a child or to make a child sleepy
- if you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Section 51727-6
Inactive ingredients
Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sodium Carboxymethylcellulose, Sucralose.
Section 53413-1
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.
Label revised: 04/24
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Drug Facts
Active ingredients (in each 10 mL) Purpose
Chlorpheniramine maleate 3.5 mg .... Antihistamine
Phenylephrine HCl 10 mg ................ Nasal decongestant
Principal Display Panel
Giltuss-D ALLERGY & CONGESTION - NDC 58552-147-04 - Bottle Label
Giltuss-D ALLERGY & CONGESTION - NDC 58552-147-04 - Carton Label
Ask A Doctor Before Use If You Have
- 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 you are
- 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
Structured Label Content
Indications and Usage (34067-9)
Uses
Temporarily relieves these Symptoms due to hay fever (allergic rhinitis) or other upper-respiratory allergies:
- runny nose
- Sneezing
- Itchy, watery eyes
- nasal congestion
- itching of the nose or throat
- sinus congestion and pressure
Dosage and Administration (34068-7)
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
|
Adults and children 12 years and over |
10 mL every 4 hours |
|
Children 6 to under 12 years |
5 mL every 4 hours |
|
Children under 6 years |
Consult a doctor |
Warnings and Precautions (34071-1)
Warnings
Section 44425-7 (44425-7)
Other information
- store at room temperature 15°-30°C (59°-86°F)
- close cap tightly
- SAVE CARTON FOR COMPLETE DRUG FACTS
Section 50566-9 (50566-9)
Stop use and ask a doctor if
- You get nervous, dizzy, or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
Section 50567-7 (50567-7)
Section 50570-1 (50570-1)
Do not use
- to sedate a child or to make a child sleepy
- if you are 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Section 51727-6 (51727-6)
Inactive ingredients
Citric Acid, Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sodium Carboxymethylcellulose, Sucralose.
Section 53413-1 (53413-1)
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.
Label revised: 04/24
MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Drug Facts
Active ingredients (in each 10 mL) Purpose
Chlorpheniramine maleate 3.5 mg .... Antihistamine
Phenylephrine HCl 10 mg ................ Nasal decongestant
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Giltuss-D ALLERGY & CONGESTION - NDC 58552-147-04 - Bottle Label
Giltuss-D ALLERGY & CONGESTION - NDC 58552-147-04 - Carton Label
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- 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 you are
- 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
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:01.944099 · Updated: 2026-03-14T23:13:40.815212