ASPIRE CONGESTION AND COUGH RELIEF DM SOFTGELS capsule, liquid filled

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]

ACTIVE INGREDIENT

Active ingredients (in each liquid gel) Purposes

Dextromethorphan HBr 10 mg – Cough Suppressant

Guaifenesin 200 mg - Expectorant

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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

WARNINGS AND PRECAUTIONS

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.

INACTIVE INGREDIENT

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 DOCTOR

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 DOCTOR/PHARMACIST

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

DO NOT USE

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

Keep out of reach of children

PREGNANCY OR BREAST FEEDING

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

PURPOSE

Active Ingredient Purpose

Guaifenesin 200 mg -Expectorant

Dextromethorphan HBr 10 mg -Cough suppressant

QUESTIONS

1-732-447-1444

STOP USE

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

When using this product do not use more than directed

WARNINGS

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81013-104
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	AR08
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81013-104-01	8000 in 1 BAG; Type 0: Not a Combination Product	04/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/14/2022

Labeler - Aspire Pharmaceuticals Inc (078797046)

Registrant - Dr Madhav Pai (078797046)