Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 5fb7ceb4-97da-4aa5-baa4-9eb2778ee2f6
Route
ORAL
Published
Effective Date 2022-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Croscarmellose Sodium Hypromellose, Unspecified Lactose Maltodextrin Cellulose, Microcrystalline Mineral Oil Povidone Magnesium Silicate Magnesium Stearate Sodium Lauryl Sulfate Stearic Acid Titanium Dioxide Triacetin Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: PH043 Shape: oval Color: white Size: 18 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-18

Description

Active ingredient - (per tablet) Guaifenesin   400 mg Phenylephrine HCl  10 mg

Purpose

Guaifenesin.......................Expectorant Phenylephrine HCl..............Nasal decongestant


Medication Information

Purpose

Guaifenesin.......................Expectorant



Phenylephrine HCl..............Nasal decongestant

Description

Active ingredient - (per tablet) Guaifenesin   400 mg Phenylephrine HCl  10 mg

Uses

Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.

  • helps loosen phlegm (mucus)
  • clear nasal passageways
  • loosens nasal congestion
  • drain bronchial tubes
  • shrinks swollen membranes
  • clears stuffy nose
  • makes coughs more productive
  • thin bronchial secretions
Section 50565-1

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison

Control Center immediately.

Section 53414-9

If pregnant or breast-feeding, ask a health

professional before use.

Section 55106-9

Active ingredient - (per tablet)

Guaifenesin   400 mg



Phenylephrine HCl  10 mg

Warnings

Do not exceed recommended dosage

Directions
  • adults and children 12 years and over: take 1 caplet every 4 hours as needed
  • children 6 to under 12 years: take 1/2 caplet every 4 hours as needed
  • children under 6 years: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Do Not Use

This product 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 are uncertain whether your prescription drug contains an MAOI, ask a health

professional.

Carton Panel

Inactive Ingredients

croscarmellose sodium, Hypromellose, lactose, magnesium silicate, magnesium stearate maltodextrin, microcrystalline cellulose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

Stop Use and Ask A Doctor If
  • nervousness, dizziness or sleeplessness occurs
  • symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus)
  • cough and congestion do not improve within 7 days or tend to recur.

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • excessive phlegm;mucus
  • difficulty in urination due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

Structured Label Content

Uses

Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.

  • helps loosen phlegm (mucus)
  • clear nasal passageways
  • loosens nasal congestion
  • drain bronchial tubes
  • shrinks swollen membranes
  • clears stuffy nose
  • makes coughs more productive
  • thin bronchial secretions
Section 50565-1 (50565-1)

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison

Control Center immediately.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health

professional before use.

Section 55106-9 (55106-9)

Active ingredient - (per tablet)

Guaifenesin   400 mg



Phenylephrine HCl  10 mg

Purpose

Guaifenesin.......................Expectorant



Phenylephrine HCl..............Nasal decongestant

Warnings

Do not exceed recommended dosage

Directions
  • adults and children 12 years and over: take 1 caplet every 4 hours as needed
  • children 6 to under 12 years: take 1/2 caplet every 4 hours as needed
  • children under 6 years: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Do Not Use (Do not use)

This product 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 are uncertain whether your prescription drug contains an MAOI, ask a health

professional.

Carton Panel

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, Hypromellose, lactose, magnesium silicate, magnesium stearate maltodextrin, microcrystalline cellulose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness or sleeplessness occurs
  • symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus)
  • cough and congestion do not improve within 7 days or tend to recur.

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • excessive phlegm;mucus
  • difficulty in urination due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

Advanced Ingredient Data


Raw Label Data

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