NEOGEN-D- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

NEOGEN-D by

Drug Labeling and Warnings

NEOGEN-D by is a Otc medication manufactured, distributed, or labeled by Kramer Novis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each 5 mL tsp)

Dextromethorphan HBr, 30 mg

Guaifenesin, 200 mg

Phenylephrine HCL, 7.5 mg

Purposes

Antitussive

Expectorant

Nasal Decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

temporarily relieves these symptoms occurring with the common cold, sinusitis, hay fever or other respiratory allergies.

     nasal congestion

     cough due to minor throat and bronchial irritation

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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

Heart disease High blood pressure Thyroid disease Diabetes Trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) a cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

When using this product do not use more than directed.

Stop use and ask a doctor if you get nervous, dizzy, or sleepless symptoms do not get better within 7 days or are accompanied by fever   cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

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

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not take more than 4 doses in any 24-hour period. Shake well before using.

Every 6-8 hours	Adults and children 12 years of age and over	Take one teaspoonful (5 mL)
	Children 6 to under 12 years of age	Take 1/2 teaspoonful (2.5 mL)
	Children under 6 years of age	Consult a doctor

Other Information

Store at controlled room temperature 15°C-30°C (59°F-86°F). Avoid excessive heat or humidity.

Tamper Evident Feature: Do not use if inner seal is torn, broken or missing.

Inactive Ingredients

Potassium sorbate, sodium benzoate, citric acid, propylene glycol, sodium citrate, sucrose, sorbitol, vegetable glycerin, sucralose, raspberry flavor and purified water

SPL UNCLASSIFIED SECTION

Contains the same active ingredients as Neo Tuss®-D*

DEXTROMETHORPHAN HBr
Antitussive

GUAIFENESIN
Expectorant

PHENYLEPHRINE HCL
Nasal Decongestant

Alcohol Free  Dye Free

Codeine Free Sugar Free

Raspberry Flavor

Manufactured in the USA for Kramer Novis, San Juan, PR 00917.

T:(787) 767-2072 www.kramernovis.com

* Neo Tuss®-D* is a registered trademark of A.G. Marin Pharmaceuticals. This product is not manufactured, distributed or marketed by A.G. Marin Pharmaceuticals.

Packaging

INGREDIENTS AND APPEARANCE

NEOGEN-D 
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-699
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	7.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-699-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/10/2018

Labeler - Kramer Novis (090158395)