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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Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate* 10 mg
*WARNING: May be habit forming
Guaifenesin 300 mg
temporarily relieves these symptoms due to the common cold:
Do not exceed recommended dosage.
Use extreme care in measuring dosage.
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 |
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.
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
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
codeine phosphate, guaifenesin liquid |
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Labeler - Cypress Pharmaceutical, Inc. (790248942) |