Aspire Congestion and Cough Relief DM Softgels by Aspire Pharmaceuticals Inc / Dr Madhav Pai

Aspire Congestion and Cough Relief DM Softgels by

Drug Labeling and Warnings

Aspire Congestion and Cough Relief DM Softgels by is a Otc medication manufactured, distributed, or labeled by Aspire Pharmaceuticals Inc, Dr Madhav Pai. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

  • Do not take more than 12 liquid gels in any 24-hour period
  • Adults and children 12 years of age and over: take 2 liquid gels every 4 hours
  • Children under 12 years of age: do not use

USES

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Temporarily relieves:
  • Cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • The intensity of coughing
  • The impulse to cough to help you get to sleep

Do not use

  • If you are now taking a prescription monamine 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 and MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Cough that occurs with too much phlegm (mucus)

When using this product do not use more than directed

Stop use and ask a doctor if

  • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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.

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

  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Cough that occurs with too much phlegm (mucus)

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

Do not use

  • If you are now taking a prescription monamine 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 and MAOI, ask a doctor or pharmacist before taking this product.

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

  • Cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

When using this product do not use more than directed

Do not use

  • If you are now taking a prescription monamine 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 and MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

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

When using this product do not use more than directed

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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.

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