Giltuss-d

Giltuss-d
SPL v4
SPL
SPL Set ID 298f5457-a7df-474d-9854-68918ee3d330
Route
ORAL
Published
Effective Date 2023-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (3.5 mg) Phenylephrine (10 mg)
Inactive Ingredients
Citric Acid Acetate Glycerin Methylparaben Propylene Glycol Propylparaben Water Carboxymethylcellulose Sodium Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-11

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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