BIOGTUSS NF- dextromethorphan, guaifenesin, phenylephrine liquid

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 5 mL tsp.)              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

• temporary relieves cough due to minor throat and bonchial irritations as may occur with the common cold or inhaled irritants
• helps loosen phlegm (mucus) and thin bronchial secretaions to make cough more productive
• temporarily relieves nasal congestion due to the common cold.

WARNINGS

Warnings

Do not use 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 do not know if you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product.

Ask a doctor before use if you have

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

Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental overdose, seek advice or a doctor or contact a Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

Directions Do not exceed 6 doses in 24 hours.

• adults and children over 12 years of age: take 1 teaspoonful (5 mL) every 6-8 hours
• children 6 to under 12 years of age: take 1/2 teaspoonful (2.5 mL) every 6-8 hours
• children under 6 years of age: consult a doctor before use

INACTIVE INGREDIENT

Inactive Ingredients  citric acid, FDandC yellow No 6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

QUESTIONS

Questions or comments? 1-305-403-3788

Monday - Friday 9:00AM - 5:00 PM EST.

Manufactured For: Advanced Generic Corporation, Miami, Fl 33147

www.advancedgeneric.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOGTUSS  NF
dextromethorphan, guaifenesin, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-242
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	28 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	388 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-242-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/01/2010

Labeler - Advanced Generic Corporation (831762971)