Drug Facts
10874e99-e7fa-4994-9af8-7e203262b1cc
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
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 51945-4
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.
Inactive Ingredients
lactose, magnesium silicate,
croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin,
microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid,
titanium dioxide and 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
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 51945-4 (51945-4)
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.
Inactive Ingredients (Inactive ingredients)
lactose, magnesium silicate,
croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin,
microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid,
titanium dioxide and 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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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:39.342812 · Updated: 2026-03-14T22:53:32.152302