Giltuss Diabetic Cough And Cold

Giltuss Diabetic Cough And Cold
SPL v6
SPL
SPL Set ID 85183b38-ce2a-0e0e-e053-2991aa0a336f
Route
ORAL
Published
Effective Date 2019-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Propylparaben Anhydrous Citric Acid Methylparaben Menthol Water Propylene Glycol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-17

Description

Drug Facts


Medication Information

Indications and Usage

Uses

  • temporarily relieves
  • cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive and drain bronchial tubes
Dosage and Administration

Directions

  • do not take more than 6 doses in any 24-hour period
  • keep dosing cup with product
  • mL = milliliters
Adults and children 12 years and over 10 mL every 4 hours
children 6 to under 12 years of age 5 mL every 4 hours
children 2 to under 6 years of age 2.5 mL every 4 hours
children under 2 years of age Do not use

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store at room temperature, between 15°- 30°C (59°- 86°F)
  • close cap tightly
  • SAVE CARTON FOR COMPLETE DRUG FACTS
Section 50565-1

Keep out of reach of children.In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts as these could be signs of a serious condition.
Section 50567-7

When using this product do not use more than directed

Section 50569-3

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema
Section 50570-1

Do not use

  • 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 MAOl 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, menthol, methylparaben, propylene glycol, propylparaben, purified water and sucralose.

Section 51945-4

Giltuss® DIABETIC

COUGH & COLD

RELIEVES

  • COUGH AND COLD
  • CHEST CONGESTION
  • LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

SAFE FOR PEOPLE WITH DIABETES

GRAPE FLAVOR

4 FL OZ (118 mL)

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.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purposes

Cough Suppressant

Expectorant

Section 55106-9

Active ingredients (in each 10 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin 200 mg

Section 60561-8

Tamper evident: do not use if safety seal is broken or missing.

PERSONS WITH DIABETES: CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING ANY MEDICATION OR DIETARY SUPPLEMENT

THIS PRODUCT DOES NOT CONTAIN ANY MEDICATION TO IMPROVE OR RELIEVE DIABETES


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves
  • cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive and drain bronchial tubes
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 doses in any 24-hour period
  • keep dosing cup with product
  • mL = milliliters
Adults and children 12 years and over 10 mL every 4 hours
children 6 to under 12 years of age 5 mL every 4 hours
children 2 to under 6 years of age 2.5 mL every 4 hours
children under 2 years of age Do not use

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store at room temperature, between 15°- 30°C (59°- 86°F)
  • close cap tightly
  • SAVE CARTON FOR COMPLETE DRUG FACTS
Section 50565-1 (50565-1)

Keep out of reach of children.In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts as these could be signs of a serious condition.
Section 50567-7 (50567-7)

When using this product do not use more than directed

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema
Section 50570-1 (50570-1)

Do not use

  • 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 MAOl 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, menthol, methylparaben, propylene glycol, propylparaben, purified water and sucralose.

Section 51945-4 (51945-4)

Giltuss® DIABETIC

COUGH & COLD

RELIEVES

  • COUGH AND COLD
  • CHEST CONGESTION
  • LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

SAFE FOR PEOPLE WITH DIABETES

GRAPE FLAVOR

4 FL OZ (118 mL)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredients (in each 10 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin 200 mg

Section 60561-8 (60561-8)

Tamper evident: do not use if safety seal is broken or missing.

PERSONS WITH DIABETES: CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING ANY MEDICATION OR DIETARY SUPPLEMENT

THIS PRODUCT DOES NOT CONTAIN ANY MEDICATION TO IMPROVE OR RELIEVE DIABETES


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)