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NDC 37808-0367-02 Mucus Relief Sinus Severe Congestion Relief 325; 200; 5 mg/1; mg/1; mg/1 Details
Mucus Relief Sinus Severe Congestion Relief 325; 200; 5 mg/1; mg/1; mg/1
Mucus Relief Sinus Severe Congestion Relief is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by HEB. The primary component is ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 37808-0367-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 37808-0367-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 37808-0367-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 37808-0367 |
|---|---|
| Product ID | 37808-367_7e2ff9cf-a312-1fc2-e053-2a91aa0a4ede |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Mucus Relief Sinus Severe Congestion Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 325; 200; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | HEB |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 37808-0367-02 (37808036702)
| NDC Package Code | 37808-367-02 |
|---|---|
| Billing NDC | 37808036702 |
| Package | 2 BLISTER PACK in 1 CARTON (37808-367-02) / 10 TABLET, COATED in 1 BLISTER PACK |
| Marketing Start Date | 2015-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9cbb3ab1-5f32-421e-9f28-d99be9447e9f Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets 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.
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.
- if you are now taking a prescription monoamine 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 an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, 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 persistent headache
These could be signs of a serious condition.
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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and older: take 2 caplets every 4 hours
- children under 12 years of age: do not use
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL
Compare to Mucinex® Sinus-Max™ Severe Congestion Relief Caplets active ingredients†
NDC 37808-367-02
H-E-B
Maximum Strength*
Mucus & Sinus Relief Severe
Acetaminophen /Pain Reliever
Guaifenesin / Expectorant
Phenylephrine / Nasal Decongestant
Congestion Relief
For Ages 12+
Relief of:
• Sinus Pressure • Headache
• Thins and Loosens Mucus
20 Caplets
INGREDIENTS AND APPEARANCE
| MUCUS RELIEF SINUS SEVERE CONGESTION RELIEF
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated |
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| Labeler - HEB (007924756) |