-free, purple liquid with a grape flavor supplied in 4 x 4 fl. oz. (118 mL) bottles (Unit of use with a 10 mL graduated oral dosing syringe and bottle Adaptor included) (NDC 51991-224-04).
STORAGE
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.
Dispense in original tight, light-resistant container with a child-resistant closure as defined in the USP/NF. Protect from freezing.
INSTRUCTIONS FOR USE OF SYRINGE
Important: follow Instructions carefully to ensure proper dosing.
To insert dispensing Plug
1)
Shake bottle well.
2)
Remove Child-Resistant cap and the safety seal from bottle.
3)
Push Dispensing Plug into neck of bottle.
4)
To ensure that the dispensing plug is fully seated, replace the child safety cap onto the bottle and turn it down completely. This will seat the dispensing plug securely in the bottle. Remove child safety cap.
To withdraw medication into syringe
1)
Before inserting the tip of the syringe into the dispensing plug, push the plunger completely down toward the tip of the syringe.
2)
Insert tip of the syringe firmly into the opening of the dispensing plug.
3)
Turn the entire unit (bottle and syringe) upside down.
4)
Pull the plunger out until the desired amount of medication is withdrawn into the syringe. (See next figure).
5)
Turn the entire unit right side up and remove the syringe from the bottle.
6)
Dispense into the child's mouth, wash syringe with tap water and store medication out of the reach of children.
NOTE: TO MAINTAIN CHILD-RESISTANT STATUS OF MEDICATION, REPLACE CHILD SAFETY CAP AFTER EACH USE.
Caution: Forceful squirting into the back of mouth can cause choking. Dispensing plug and syringe should be used for one drug product and one patient only. The dispensing plug is not a childproof closure.
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.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Rx Only
Manufactured by: Deltex Pharmaceuticals, Inc.
Rosenberg, TX 77471
Distributed by: Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487
ISS. 10/07
MG #21477
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
Breckenridge
Pharmaceutical, Inc.
NDC 51991-224-04
Updated Labeling
CV
Coldcough™ PD
Syrup
Antitussive/Decongestant/Antihistamine
Alcohol Free • Sugar Free
Each 5 mL (one teaspoonful) contains:
Dihydrocodeine Bitartrate* 3.0 mg
*(Warning: May be habit-forming)
Chlorpheniramine Maleate 2.0 mg
Phenylephrine Hydrochloride 7.5 mg
Grape Flavor
DO NOT USE IF INNER SEAL
IS BROKEN OR MISSING
Rx Only
4 fl. oz. (118 mL)
COLDCOUGH PD
dihydrocodeine bitartrate, chlorpheniramine maleate, and phenylephrine hydrochloride syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-224
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dihydrocodeine Bitartrate(Dihydrocodeine) Dihydrocodeine Bitartrate 3mg in5mL
Chlorpheni