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

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GANITUSS NR LIQUID

Active ingredients

Active ingredients                          Purpose
(in each 5 mL teaspoonful)
Codeine Phosphate* 10 mg.................... Antitussive
*WARNING: May be habit forming.
Guaifenesin 100 mg............................... 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 NDC Product Code (Source) 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 No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 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

Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 12/2009Cypress Pharmaceutical, Inc.