BIOGTUSS TR- guaifenesin, phenylephrine hcl, dextromethorphan hbr tablet

Biogtuss by

Drug Labeling and Warnings

Biogtuss by is a Otc medication manufactured, distributed, or labeled by Advanced Generic Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each tablet)           Purpose

Dextromethorphan HBR .... 28 mg ............ Cough Suppressant

Guaifenesin ..................... 388 mg ...........  Expectorant

Phenylephrine HCl ............  10 mg ..........   Nasal Decongestant

PURPOSE

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

Uses

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

• helps loosen phlegm (mucus)
• loosens nasal congestion
• thin bronchial secretions
• drain bronchial tubes
• cough and coughing and calms the cough control center
• make coughs more productive
• clears stuffy nose
• clear nasal passageways
• shrinks swollen membranes

WARNINGS

Warnings

Do not exceed recommended dosage

Do not use this product if you are taking a 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.

Ask a doctor before use if you have:

• heart disease
• excessive phlegm (mucus)
• high blood pressure
• diabetes
• thyroid disease
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product do not use more than directed

STOP USE

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 are accompanied by fever or symptoms tend to recur.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions: Do not exceed recommended doses in a 24-hour period

Adults and children 12 years of age and over              1 tablet every 4 hours. Do not exceed 4 tablets in 24 hours

Children 6 to 12 years of age                                       1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours

Children under 6 years of age                                      Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients: Colloidal silicon dioxide, crocarmellose sodium, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, talc

QUESTIONS

Questions or comments? 305-403-3788

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOGTUSS  TR
guaifenesin, phenylephrine hcl, dextromethorphan hbr tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-605
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	388 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	28 mg

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	BG;AGC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-605-10	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/2014

Labeler - Advanced Generic Corporation (831762971)