ASPIRE DAY CONGESTION AND HEADACHE SOFTGEL- aspire day congestion and headache softgel capsule, liquid filled 
ASPIRE NIGHT COLD AND FLU SOFTGEL- aspire night cold and flu softgel capsule, liquid filled 
ASPIRE DAYTIME MUCUS AND SINUS SOFTGEL- aspire daytime mucus and sinus softgel 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
Acetaminophen 325 mg - Pain reliever/fever reducer
Dextromethorphan HBr 10 mg - Cough suppressant
Guaifenesin 200 mg - Expectorant
Phenylephrine HCl 5 mg - Nasal Decongestant

DIRECTIONS

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

WARNINGS

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not use more than directed

Stop use and ask a doctor if

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

USES

Nasal congestion

Headache

Cough

Minor aches and pains

Sore throat

INACTIVE INGREDIENTS

Polyethylene Glycol, Unspecified

Propylene Glycol

Povidone, Unspecified

Gelatin, Unspecified

Glycerin

Sorbitol

Purified Water

Lecithin, Sunflower

Light Mineral oil

FD&C Colors

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Do not use

Keep out of reach of children.

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

Active Ingredient Purpose

Acetaminophen 325 mg -Pain reliever/fever reducer
Dextromethorphan HBr 10 mg -Cough suppressant
Guaifenesin 200 mg -Expectorant
Phenylephrine HCl 5 mg -Nasal Decongestant

1-732-447-1444

Stop use and ask a doctor if

When using this product do not use more than directed

Active ingredients in each liquid gel -Purposes

Acetaminophen 325 mg-Pain reliever/fever reducer

Dextromethorphan HBr 10 mg -Cough suppressant

Doxylamine Succinate 6.25 mg - Antihistamine

Phenylephrine HCl 5 mg-Nasal Decongestant

DIRECTIONS

OVERDOSE WARNING

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

WARNINGS

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

USES

INACTIVE INGREDIENTS

Polyethylene Glycol, Unspecified

Propylene Glycol

Povidone, Unspecified

Gelatin, Unspecified

Glycerin

Sorbitol

Purified Water

Lecithin, Sunflower

Light Mineral oil

FD&C Colors

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Do not use

Keep out of reach of children.

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

Active ingredients Purposes
Acetaminophen 325 mg -Pain reliever/fever reducer
Dextromethorphan HBr 10 mg -Cough suppressant
Doxylamine succinate 6.25 mg -Antihistamine
Phenylephrine HCl 5 mg -Nasal decongestan

1-732-447-1444

Stop use and ask a doctor if

When using this product

Active ingredients (in each liquid gel) Purposes

Acetaminophen 325 mg -Pain reliever/fever reducer

Dextromethorphan HBr 10 mg -Cough suppressant

Phenylephrine HCl 5 mg -Nasal decongestant

DIRECTIONS

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

WARNINGS

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

USES

INACTIVE INGREDIENTS

Polyethylene Glycol, Unspecified

Propylene Glycol

Povidone, Unspecified

Gelatin, Unspecified

Glycerin

Sorbitol

Purified Water

Lecithin, Sunflower

Light Mineral oil

FD&C Colors

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Do not use

Keep out of reach of children.

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

Active ingredients (in each liquid gel) Purposes

Acetaminophen 325 mg -Pain reliever/fever reducer

Dextromethorphan HBr 10 mg -Cough suppressant

Phenylephrine HCl 5 mg -Nasal decongestant

1-732-447-1444

Stop use and ask a doctor if

When using this product do not use more than directed

Aspire Daytime Mucus and Sinus Softgel

Aspire Night Cold and Flu Softgels

Aspire Day Congestion and Headache Softgels

ASPIRE DAY CONGESTION AND HEADACHE SOFTGEL 
aspire day congestion and headache softgel capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81013-103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorredScoreno score
ShapeOVAL (OBLONG SHAPE) Size21mm
FlavorImprint Code AR04
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81013-103-015000 in 1 BAG; Type 0: Not a Combination Product03/17/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/17/2021
ASPIRE NIGHT COLD AND FLU SOFTGEL 
aspire night cold and flu softgel capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81013-102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorgreenScoreno score
ShapeOVAL (OBLONG SHAPE) Size21mm
FlavorImprint Code AR03
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81013-102-015000 in 1 BAG; Type 0: Not a Combination Product03/17/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/17/2021
ASPIRE DAYTIME MUCUS AND SINUS SOFTGEL 
aspire daytime mucus and sinus softgel capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81013-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColororangeScoreno score
ShapeOVAL (OBLONG SHAPE) Size25mm
FlavorImprint Code AR01
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81013-101-014000 in 1 BAG; Type 0: Not a Combination Product03/17/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/17/2021
Labeler - Aspire Pharmaceuticals Inc. (078797046)
Registrant - Dr Madhav Pai (078797046)
Establishment
NameAddressID/FEIBusiness Operations
Aspire Pharmaceuticals Inc.078797046manufacture(81013-101, 81013-102, 81013-103)

Revised: 1/2023
Document Id: f1f406b0-c983-63ab-e053-2a95a90ad8c3
Set id: b3397e24-4cda-ac0a-e053-2a95a90afae2
Version: 5
Effective Time: 20230110
 
Aspire Pharmaceuticals Inc.