DEX-TUSS - 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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Dex-Tuss Liquid

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Codeine Phosphate* 10 mg
*WARNING:  May be habit forming
Guaifenesin 300 mg

Purpose

Cough Suppressant
Expectorant

Uses

temporarily relieves these symptoms due to the common cold:

  • 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.
Use extreme care in measuring dosage.

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.

Stop use and ask a doctor if

  • a cough that 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

When using this product

  • may cause or aggravate constipation

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose seek professional assistance or contact a poison control center immediately.

Directions

Take this medication with a full glass of water after each dose to help loosen mucus in the lungs.  Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Adults and children
12 years of age
and over:


1 teaspoonful (5 mL)
every 4 to 6 hours, not
to exceed 8 teaspoonfuls
in 24 hours, or as
directed by a doctor.
Children 6 to under
12 years of age:



1/2 teaspoonful (2.5 mL)
every 4 to 6 hours, not to
exceed 4 teaspoonfuls
in 24 hours, or as
directed by a doctor.
Children under 6
years of age:
Consult a physician


Other information

Store at 25°C- 77°F, excursions permitted 15°C to 30°C (59° to 86°F).

Inactive ingredients

Citric Acid, FD and C Blue #1, FD and C Red #40, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, and Sorbitol.

Questions? Comments?

1-800-856-4393
M-F: 8:00 a.m. - 5:00 p.m. CT
Serious side effects associated with use of this product may be reported to this number.



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

Product Packaging:

The packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 60258-530-16

Dex-Tuss
Liquid

COUGH SUPPRESSANT
EXPECTORANT

CV

Each teaspoonful (5 mL) for oral administration
contains:


Codeine Phosphate*...............................10 mg
*(WARNING:  May be habit-forming)
Guaifenesin..........................................300 mg

SUGAR FREE / ALCOHOL FREE
GLUTEN FREE

Grape Flavor

CYPRESS
PHARMACEUTICAL, INC.

16 fl oz (473 mL)


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

L709                  Rev. 05/11

Dex-Tuss Packaging
Dex-Tuss Packaging

DEX-TUSS 
codeine phosphate, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:60258-530
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (Codeine Anhydrous) Codeine Phosphate10 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin300 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60258-530-16473 mL in 1 BOTTLE; Combination Product Type = C112160
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/28/201101/06/2014
Labeler - Cypress Pharmaceutical, Inc. (790248942)

Revised: 1/2015
 
Cypress Pharmaceutical, Inc.