ASPIRE MUCUS AND PAIN RELIEF SOFTGELS- aspire mucus and pain relief 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
Acetaminophen 325 mg - Pain reliever/fever reducer
Guaifenesin 200 mg - Expectorant

DIRECTIONS

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

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

FD&C blue no. 1, Gelatin, Glycerin, Hypromellose, 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 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 reduce

Guaifenesin 200 mg -Expectorant

1-732-447-1444

Stop use and ask a doctor if

When using this product do not use more than directed

Aspire Mucus and Pain Relief Softgels Rev-01

ASPIRE MUCUS AND PAIN RELIEF SOFTGELS 
aspire mucus and pain relief softgels capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81013-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE K30 (UNII: U725QWY32X)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
Product Characteristics
Colorblue (Opaque Navy Blue) Scoreno score
ShapeOVAL (Oblong Shape) Size22mm
FlavorImprint Code AR09
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81013-105-016000 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: f43ab341-0829-b18c-e053-2995a90ac22b
Set id: dbc83501-9401-2a8d-e053-2a95a90a45c5
Version: 3
Effective Time: 20230208
 
Aspire Pharmaceuticals Inc.