DEXTROMETHORPHAN HBR 15 MG- dextromethorphan hbr 15 mg capsule, liquid filled 
AMZ789 LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DEXTROMETHORPHAN HBR 15 MG

Dextromethorphan HBr, USP 15 mg

Cough suppressant

Use

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

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.

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

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

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

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DEXTROMETHORPHAN HBR 15 MG 
dextromethorphan hbr 15 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73629-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorred (CLEAR) Scorescore with uneven pieces
ShapeOVAL (CAPSULE) Size10mm
FlavorImprint Code PC6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73629-005-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2022
Labeler - AMZ789 LLC (117410213)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd421293287manufacture(73629-005)

Revised: 5/2022
Document Id: e2175022-de7e-17cd-e053-2995a90aa144
Set id: e2175017-6a0d-0155-e053-2995a90a65d6
Version: 1
Effective Time: 20220501
 
AMZ789 LLC