DEXTROMETHORPHAN HYDROBROMIDE capsule, liquid filled

DEXTROMETHORPHAN HYDROBROMIDE by

Drug Labeling and Warnings

DEXTROMETHORPHAN HYDROBROMIDE by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Dextromethorphan HBr, USP 15mg

Purpose

Cough suppressant

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

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

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

Stop use and ask doctor if cough lasts for 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 orcontact a Poison Control Center right away.

Directions

• do not take more than 8 softgels in any 24-hour period
• this adult product is not intended for use in children under 12 years of age

• adults and children 12 years and over: take 2 capsules every 6 to 8 hours, as needed
• 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)
• protect from light

Inactive ingredients

 FD&C red no. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, sorbitol sorbitan, titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredient of
ROBITUSSIN ® LONG ACTING COUGH GELS ©*

VALUMEDS™

ADULT LONG-LASTING
Cough Relief FOR AGES 12 & OVER

Dextromethorphan HBr, 15 mg

Cough suppressant

Relieves cough for up to 8 hours

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HYDROBROMIDE 
dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0106
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

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

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	404
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0106-1	1 in 1 CARTON	04/10/2018
1		15 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68210-0106-2	1 in 1 CARTON	03/12/2020
2		240 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 68210-0106-3	1 in 1 CARTON	03/12/2020
3		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/10/2018

Labeler - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PVT LTD		677385498	manufacture(68210-0106)