DIMACOL- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup

Dimacol by

Drug Labeling and Warnings

Dimacol by is a Other medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL - Shipping Label

1 Tote of 220 Gallons

0031-8729-01

GROSS: __________________

TARE: ___________________

NET: ____________________

Dimacol

FOR EXPORT

CAUTION: FOR MANUFACTURING, PROCESSING, OR REPACKING ONLY
STORE AT 20-25°C (68-77°F)

Must be repackaged by

LOT
MFD

Manufactured by:
Fareva Richmond Inc.,
Henrico, VA 23231 EUA

Made in USA

1

INGREDIENTS AND APPEARANCE

DIMACOL 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 0031-8729
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8729-01	75708 mL in 1 CONTAINER	09/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		09/01/2015

Labeler - Haleon US Holdings LLC (079944263)