mic and should be treated with fluids. Endotracheal intubation and
artificial respiration may be necessary. The pure opioid antagonist naloxene or nalmexone is a
specific antidote against respiratory depression that results from opioid overdose. Opioid antagonists
should not be given in the absence of clinically significant respiratory or circulatory depression
secondary to opioid overdose. They should be administered cautiously to persons who are known, or
suspected to be, physically dependent on any opioid agonist including dihydrocodeine. In such cases,
an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The
prescribing information for the specific opioid antagonist should be consulted for details of their
proper use.
DOSAGE AND ADMINISTRATION
Adults and children over 12 years: 1 to 2 teaspoonfuls (5 mL to 10 mL) every 4 to 6 hours,
as needed. Children 6 to under 12 years of age: 1/2 to 1 teaspoonful (2.5 mL to 5 mL)
every 4 to 6 hours, as needed.
Not recommended for children under 6 years of age.
HOW SUPPLIED
Poly-Tussin EX is supplied as a clear colorless, alcohol free, gluten free, sugar free,
dye free syrup with a grape flavor in 16 fl oz (473 mL) bottles, NDC 50991-529-16,
and 15 mL professional sample (NDC 50991-529-15)
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONALASSISTANCE
OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Store at controlled room temperature, 15o-30oC (59o-86oF).
(On 16 fl oz Bottle:)
Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
This bottle is not to be dispensed to consumer.
(On 15 mL Bottle:)
Supplied in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
Rx only
Distributed for:
Poly Pharmaceuticals
Mobile, AL 36619
PRODUCT PACKAGING:
The packaging below represents the labeling currently used:
Principal Display Panel and Side Panel for 473 mL Label:
NDC 50991-529-16
POLY-TUSSIN EX
Antitussive / Decongestant / Expectorant
Each 5 mL (1 teaspoonful) contains:
Dihydrocodeine Bitartrate*........ 7.5 mg
*(WARNING: May be habit forming)
Phenylephrine HCl.................... 5 mg
Guaifenesin............................ 50 mg
Grape Flavor
Alcohol Free / Gluten Free
Sugar Free / Dye Free
CIII
Rx Only
Distributed by:
Poly Pharmaceuticals
Mobile, AL 36619
16 fl oz. (473 mL)
Side Panel:
Adults and children over 12 years: 1 to 2 teaspoonfuls (5 mL to 10 mL) every 4 to 6 hours, as needed.
Children 6 to under 12 years of age: 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, as needed.
Not recommended for children under 6 years of age.
Refer to the attached package insert for full prescribing information.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE
OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT
A POISON CONTROL CENTER IMMEDIATELY.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Storage: Store at controlled room temperature, 15o-30oC (59o-86oF).
Dispense in a tight, light-resistant container with a child-resista
