IOPHEN C NR - codeine phosphate and guaifenesin liquid 
Qualitest Pharmaceuticals

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IOPHEN C-NR LIQUID

CV

Active ingredients (in each 5 mL = 1 tsp)

Codeine phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough suppressant

Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• calms the cough control center and relieves coughing

Warnings

Do not use

• in a child under 2 years of age
• if you or your child has a chronic pulmonary disease or shortness of breath
• if your child is taking other drugs, unless directed by a doctor

Ask a doctor before use if you have

• cough that occurs with excessive phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product constipation may occur or be aggravated

Stop use and ask a doctor if 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

• take every 4 hours
• do not take more than 6 doses in any 24-hour period

adults and children 12 years and over	take 10 mL (2 tsp)
children 6 years to under 12 years	take 5 mL (1 tsp)
children 2 years to under 6 years	consult a doctor
children under 2 years	do not use

Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other information

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

citric acid, FD&C red #40, glycerin, propylene glycol, purified water, red raspberry flavor, saccharin sodium, sodium benzoate, sorbitol solution

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 10/09 R6 8066070 1329

PRINCIPAL DISPLAY PANEL

IOPHEN C NR  codeine phosphate and guaifenesin   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0603-1329 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   D&C RED NO. 40   GLYCERIN   PROPYLENE GLYCOL   WATER   SACCHARIN SODIUM   SODIUM BENZOATE   SORBITOL

Product Characteristics Color RED (clear) Score      Shape Size Flavor RASPBERRY (red raspberry) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0603-1329-58 473 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/01/1997

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		958430845	MANUFACTURE

Revised: 12/2009Qualitest Pharmaceuticals