Giltuss Hbp Cough & Chest Congestion

Giltuss Hbp Cough & Chest Congestion
SPL v7
SPL
SPL Set ID 852ceea2-d6a1-6de2-e053-2a91aa0ad50d
Route
ORAL
Published
Effective Date 2019-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (200 mg)
Inactive Ingredients
D&c Red No. 33 Water Sucrose Anhydrous Citric Acid Propylparaben Propylene Glycol Methylparaben

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-13

Description

Drug Facts


Medication Information

Indications and Usage

Uses

  • temporarily relieves
  • cough due to minor throat and bronchial irritation as may occur with the 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 cough more productive
Dosage and Administration

Directions

  • do not exceed recommended dosage
  • do not take more than 6 doses in any 24 hour period
  • keep dosing cup for use with this product
  • mL = milliliters
adults and children 12 years & 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 Consult a doctor

Description

Drug Facts

Section 42229-5

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 persistent headache. 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 such as occurs with smoking, chronic bronchitis, or emphysema
Section 50570-1

Do not useif 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, D&C red #33, flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose

Section 51945-4

MAXIMUM STRENGTH

HBP GILTUSS ®

COUGH & CHEST CONGESTION

ANTITUSSIVE AND EXPECTORANT

ALCOHOL FREE. NON-DROWSY

RELIEVES

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

RASPBERRY FLAVOR

4FL 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


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves
  • cough due to minor throat and bronchial irritation as may occur with the 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 cough more productive
Dosage and Administration (34068-7)

Directions

  • do not exceed recommended dosage
  • do not take more than 6 doses in any 24 hour period
  • keep dosing cup for use with this product
  • mL = milliliters
adults and children 12 years & 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 Consult a doctor

Section 42229-5 (42229-5)

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 persistent headache. 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 such as occurs with smoking, chronic bronchitis, or emphysema
Section 50570-1 (50570-1)

Do not useif 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, D&C red #33, flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose

Section 51945-4 (51945-4)

MAXIMUM STRENGTH

HBP GILTUSS ®

COUGH & CHEST CONGESTION

ANTITUSSIVE AND EXPECTORANT

ALCOHOL FREE. NON-DROWSY

RELIEVES

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

RASPBERRY FLAVOR

4FL 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


Advanced Ingredient Data


Raw Label Data

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