drug facts

drug facts
SPL v1
SPL
SPL Set ID ab7ca98a-e6ca-4f91-a199-e69b9c86b4e2
Route
oral
Published
Effective Date 2014-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (400 mg) phenylephrine (10 mg)
Inactive Ingredients
croscarmellose sodium lactose maltodextrin cellulose, microcrystalline mineral oil povidone magnesium silicate magnesium stearate

Identifiers & Packaging

Pill Appearance
Imprint: RCCGPE;C27 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
otc monograph final active Since 2006-06-05

Purpose

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

Description

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


Medication Information

Warnings

Do not exceed recommended dosage





Active Ingredient

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

Purpose

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



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

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.



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



Description

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

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.



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.

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

Warnings

Do not exceed recommended dosage





Active Ingredient (55106-9)

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

Purpose

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



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

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.



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



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.



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.

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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