GANITUSS NR - codeine phosphate and guaifenesin liquid
Cypress Pharmaceutical, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate* 10 mg
*WARNING: May be habit forming.
Guaifenesin 100 mg

Purpose

Antitussive
Expectorant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

cough due to minor throat and bronchial irritation
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make 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 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

a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)
chronic pulmonary disease or shortness of breath, or children who are taking other drugs
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
new symptoms occur
product may cause or aggravate constipation

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

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

Directions

Take this medication with a full glass of water after each dose to help loosen mucus in the lungs.

Adults and children 12 years of age and over:	1 teaspoonful (5 mL) every 4 hours, not to exceed 8 teaspoonfuls in 24 hours
Children 6 to under 12 years of age:	1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 4 teaspoonfuls in 24 hours
*Children under 6 years of age	Consult a doctor

*Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other information

Store at 59o-86oF (15o-30oC)

Inactive ingredients

Citric Acid, FD and C Red #40, Glycerin, Propylene Glycol, Purified Water, Raspberry Flavor,
Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

Serious side effects associated with use of this product may be reported to this number. Call 1-800-856-4393
Mon. - Fri. (8 a.m. to 5 p.m. CST)

Manufactured for:
Cypress Pharmaceutical, Inc.
Madison, MS 39110

L677 Rev. 11/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

NDC 60258-261-16

GANITUSS NR
LIQUID

ANTITUSSIVE / EXPECTORANT
SUGAR FREE / ALCOHOL FREE

Each teaspoonful (5 mL) contains:

Codeine Phosphate*......... 10 mg
*WARNING: May be habit forming.
Guaifenesin USP............ 100 mg

CV

Raspberry Flavor

Rx Only

CYPRESS PHARMACEUTICAL, INC.

16 fl oz (473 mL)

Side Panel:

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant closure.

THIS BOTTLE SHOULD NOT BE DISPENSED TO CONSUMER.

Mfg. for: Cypress Pharmaceutical, Inc., Madison, MS 39110

L677 Rev. 11/09

GANITUSS NR
codeine phosphate, and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60258-261
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Codeine Phosphate (Codeine)	Codeine Phosphate	10 mg in 5 mL
Guaifenesin (Guaifenesin)	Guaifenesin	100 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Citric Acid
Glycerin
Propylene Glycol
Water
Sodium Citrate
Saccharin Sodium
Sorbitol

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:60258-261-16	473 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/01/1995	08/26/2011

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 08/2011 Cypress Pharmaceutical, Inc.