n appropriate cathartic.
Gastric lavage may be necessary. Hypotension is usually hypovolemic and should be
treated with fluids. Endotracheal intubation and artificial respiration may be necessary.
The pure opioid antagonist naloxone 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
Donatuss DC Syrup is supplied as a alcohol free, gluten free syrup with a grape flavor
in 16 fl oz (473 mL) bottles, NDC 16477-136-16, and 15 mL professional samples,
NDC 16477-136-15.
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.
Store at controlled room temperature, 15o-30oC (59o-86oF).
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Dispense in a tight, light-resistant container as defined in the USP/NF with a
child-resistant closure. (This statement is only on the 16 oz. Label)
This bottle is not to be dispensed to consumer. (This statement is only on the 16 oz label)
Supplied in a tight, light-resistant container as defined in the USP/NF with a child-resistant
closure. (This statement is only on the 15 mL Label)
RX Only
Manufactured for:
Laser Pharmaceuticals, Inc.
Greenville, SC 29615
Manufactured by:
Great Southern Laboratories
Houston, TX 77099
Rev. 09/09
PRODUCT PACKAGING
The packaging below represents the labeling currently used.
Principal Display Panel and Side Panel for 16 oz. (473 mL) Label:
NDC 16477-136-16
Donatuss DC
SYRUP
Rx
Antitussive
Decongestant
Expectorant
Each 5 mL (1 teaspoonful) contains:
Dihydrocodeine Bitartrate* ... 7.5 mg
(WARNING: May be habit-forming.)
Phenylephrine HCl ............. 7.5 mg
Guaifenesin ....................... 50 mg
Alcohol Free / Gluten Free
Rx Only 16 fl oz (473 mL)
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.
Store at controlled room temperature 15o-30oC (59o-86oF).
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
This bottle is not to be dispensed to consumer.
Pharmacist: Dispense in a tight, light-resistant container with a child-resistant
closure as defined in the USP/NF.
