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NDC 72854-0265-04 MUCINEX INSTASOOTHE 7; 1 g/100mL; g/100mL Details
MUCINEX INSTASOOTHE 7; 1 g/100mL; g/100mL
MUCINEX INSTASOOTHE is a ORAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is BENZOCAINE; MENTHOL, UNSPECIFIED FORM.
Product Information
| NDC | 72854-0265 |
|---|---|
| Product ID | 72854-265_49503b64-761f-4d3c-84fc-acd896feb8c6 |
| Associated GPIs | 88359902150920 |
| GCN Sequence Number | 082564 |
| GCN Sequence Number Description | benzocaine/menthol SPRAY 7 %-1 % MUCOUS MEM |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 50018 |
| HICL Sequence Number | 001675 |
| HICL Sequence Number Description | BENZOCAINE/MENTHOL |
| Brand/Generic | Brand |
| Proprietary Name | MUCINEX INSTASOOTHE |
| Proprietary Name Suffix | SORE THROAT PLUS PAIN RELIEF |
| Non-Proprietary Name | BENZOCAINE and Menthol, Unspecified Form |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SPRAY |
| Route | ORAL |
| Active Ingredient Strength | 7; 1 |
| Active Ingredient Units | g/100mL; g/100mL |
| Substance Name | BENZOCAINE; MENTHOL, UNSPECIFIED FORM |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part356 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 72854-0265-04 (72854026504)
| NDC Package Code | 72854-265-04 |
|---|---|
| Billing NDC | 72854026504 |
| Package | 115 mL in 1 BOTTLE, SPRAY (72854-265-04) |
| Marketing Start Date | 2021-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6140d487-d87c-4954-9247-83492bcc5738 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
Methemoglobinemia warning
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Allergy alert
Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.
Directions
| children 12 years of age and older | apply to affected area (one spray); gargle, swish around in the mouth, or allow to remain in place at least 1 minute then spit out. Use up to 4 times daily or as directed by a doctor. |
| children 6 to under 12 years of age | supervise use |
| children under 6 years of age | do not use |
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 115 mL Bottle Label
INGREDIENTS AND APPEARANCE
| MUCINEX INSTASOOTHE
SORE THROAT PLUS PAIN RELIEF
benzocaine and menthol, unspecified form spray |
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| Labeler - RB Health (US) LLC (081049410) |
Revised: 6/2021
Document Id: 49503b64-761f-4d3c-84fc-acd896feb8c6
Set id: 6140d487-d87c-4954-9247-83492bcc5738
Version: 1
Effective Time: 20210610