Label: ASPIRE MUCUS AND PAIN RELIEF SOFTGELS capsule, liquid filled
- NDC Code(s): 81013-105-01
- Packager: Aspire Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
-
WARNINGS
WARNINGS
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 liquid gels in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- 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 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
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with 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.
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.
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- PURPOSE
- QUESTIONS
- STOP USE
- WHEN USING
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASPIRE MUCUS AND PAIN RELIEF SOFTGELS
aspire mucus and pain relief softgels capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81013-105 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength 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 Color blue (Opaque Navy Blue) Score no score Shape OVAL (Oblong Shape) Size 22mm Flavor Imprint Code AR09 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81013-105-01 6000 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)