Sunmark chest congestion relief pepe tablet

Otc - active ingredient section

Active ingredient- (per tablet)

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purpose

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

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

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

Warnings

Do not exceed recommended dosage



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 Parkinsons 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.

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

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.

Otc - pregnancy or breast feeding section


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

Otc - keep out of reach of children section

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

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

Ingredients and appearance - Product information

Sunmark chest congestion relief pepe tablet- Guaifenesin/phenylephrine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 49348-774
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 400 mgin 1
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Lactose ( UNII: J2B2A4N98G)
Maltodextrin ( UNII: 7CVR7L4A2D)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Mineral oil ( UNII: T5L8T28FGP)
Povidone ( UNII: FZ989GH94E)
Magnesium silicate ( UNII: 9B9691B2N9)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color white Score 2
Shape OVAL Imprint Code RCCGPE;C27
Size 17 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Strategic Sourcing Services LLC( 116956644)

Establishment

Name ID/FEI Business Operations
Strategic Sourcing Services LLC 116956644 relabel( 49348-774), repack( 49348-774)

Package label.principal display panel

Sunmark Chest Congestion Relief PE PE label image