DEXTROMETHORPHAN HBR 15 MG capsule, liquid filled

DEXTROMETHORPHAN HBR 15 MG by

Drug Labeling and Warnings

DEXTROMETHORPHAN HBR 15 MG by is a Otc medication manufactured, distributed, or labeled by AMZ789 LLC, Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dextromethorphan HBr, USP 15 mg

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.

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 a 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 or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

do not take more than 8 capsules 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 of age and over:

  take 2 capsules every 6 to 8 hours, as needed

• children under 12 years of age:

  do not use

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

FD&C blue #1, FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HBR 15 MG 
dextromethorphan hbr 15 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73629-005
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
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GELATIN (UNII: 2G86QN327L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red (CLEAR)	Score	score with uneven pieces
Shape	OVAL (CAPSULE)	Size	10mm
Flavor		Imprint Code	PC6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73629-005-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2022

Labeler - AMZ789 LLC (117410213)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd		421293287	manufacture(73629-005)