Label: ASPIRE CONGESTION AND COUGH RELIEF DM SOFTGELS capsule, liquid filled
- NDC Code(s): 81013-104-01
- Packager: Aspire Pharmaceuticals Inc
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 8, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
-
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
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
- PREGNANCY OR BREAST FEEDING
- PURPOSE
- QUESTIONS
- STOP USE
- WHEN USING
-
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 filledProduct 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)
