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Iophen NR

Medically reviewed on March 30, 2018

Dosage form: liquid
Ingredients: GUAIFENESIN 100mg in 5mL
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-1328

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.

IOPHEN NR LIQUID

Active ingredient (in each 5 mL = 1 tsp)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Use

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warning

Do not use in a child under 2 years of age

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

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 to 20 mL (2 to 4 tsp)

children 6 years to under 12 years

take 5 to 10 mL (1 to 2 tsp)

children 2 years to under 6 years

take 2.5 to 5 mL (1/2 to 1 tsp)

children under 2 years

do not use

Attention: Only use the measuring spoons or cups that are made specially for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines.

Other information
  • each tsp contains: sodium 2 mg
  • 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

caramel color, citric acid, 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. 2/15 R5 8066055 1328

PRINCIPAL DISPLAY PANEL
IOPHEN NR 
guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-1328
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARAMEL 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SORBITOL 
Product Characteristics
ColorBROWN (clear/light brown) Score    
ShapeSize
FlavorRASPBERRY (red raspberry) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-1328-58473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/01/199707/20/2018
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE(0603-1328)

 
Qualitest Pharmaceuticals

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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