ASPIRE CONGESTION AND COUGH RELIEF DM SOFTGELS- aspire congestion and cough relief dm softgels capsule, liquid filled 
Aspire Pharmaceuticals Inc

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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Active ingredients (in each liquid gel) Purposes

Dextromethorphan HBr 10 mg – Cough Suppressant

Guaifenesin 200 mg - Expectorant

DIRECTIONS

USES

Do not use

Ask a doctor before use if you have

When using this product do not use more than directed

Stop use and ask a doctor if

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

Keep out of reach of children.

D&C yellow no. 10, FD&C blue no. 1, Gelatin, Glycerin, Lecithin, Light mineral oil, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if your prescription drug contains and MAOI

Do not use

Keep out of reach of children

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

Active Ingredient Purpose

Guaifenesin 200 mg -Expectorant

Dextromethorphan HBr 10 mg -Cough suppressant

1-732-447-1444

Stop use and ask a doctor if

When using this product do not use more than directed

Do not use

Ask a doctor before use if you have

When using this product do not use more than directed

Stop use and ask a doctor if

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

Keep out of reach of children.

Aspire Congestion and Cough Relief DM Softgels -Rev-01

ASPIRE CONGESTION AND COUGH RELIEF DM SOFTGELS 
aspire congestion and cough relief dm softgels capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81013-104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE K12 (UNII: 333AG72FWJ)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize15mm
FlavorImprint Code AR08
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81013-104-018000 in 1 BAG; Type 0: Not a Combination Product04/14/2022
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/14/2022
Labeler - Aspire Pharmaceuticals Inc (078797046)
Registrant - Dr Madhav Pai (078797046)

Revised: 2/2023
Document Id: f43a9389-c644-ce49-e053-2a95a90a537f
Set id: dbc517f5-ac4e-6ad3-e053-2a95a90a5aee
Version: 3
Effective Time: 20230208
 
Aspire Pharmaceuticals Inc