Drug Facts

Active ingredients (in each softgel)	Purposes
Dextromethorphan HBr, USP 10 mg	Cough suppressant
Guaifenesin, USP 200 mg	Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not take more than 12 softgels in any 24-hour period
this adult product is not intended for use in children under 12 years of age

age	dose
adults and children 12 years and over	2 softgels every 4 hours
children under 12 years	do not use

Other information

store at 20-25°C (68-77°F).
avoid excessive heat above 40°C (104°F).

Inactive ingredients

FD&C Red-40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, special sorbitol, titanium dioxide

Questions or comments?

1-888-333-9792

DISTRIBUTED BY:
SPIRIT PHARMACEUTICALS LLC

RONKONKOMA, NY 11779

PRINCIPAL DISPLAY PANEL

VALUMEDS TM

Compare to the active ingredients in Robitussin® Maximum

Strength Cough+Chest Congestion DM*

Maximum Strength

Cough + Chest Congestion DM

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN/ EXPECTORANT

MAXIMUM STRENGTH

Relieves

cough
mucus

10 SOFTGELS
Liquid Filled capsules

image description

MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
dextromethorphan hydrobromide and guaifenesin capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68210-4107
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red (Light red)	Score	no score
Shape	OVAL (Oblong)	Size	20mm
Flavor		Imprint Code	242;905
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68210-4107-1	1 in 1 CARTON	07/30/2020
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	07/30/2020

Labeler - Spirit Pharmaceuticals LLC (179621011)

MAXIMUM STRENGTH COUGH+CHEST CONGESTION DM