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NDC 42507-0336-06 Mucus Relief Cold Flu and Sore Throat 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL Details
Mucus Relief Cold Flu and Sore Throat 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
Mucus Relief Cold Flu and Sore Throat is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Hy-Vee. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; 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: 42507-0336-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 42507-0336-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 42507-0336-06Last 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: 42507-0336-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 42507-0336 |
|---|---|
| Product ID | 42507-336_bd0fa0e6-c088-461c-87a2-ed2f67673aa4 |
| 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 Cold Flu and Sore Throat |
| Proprietary Name Suffix | Maximum Strength |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 650; 20; 400; 10 |
| Active Ingredient Units | mg/20mL; mg/20mL; mg/20mL; mg/20mL |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Hy-Vee |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 42507-0336-06 (42507033606)
| NDC Package Code | 42507-336-06 |
|---|---|
| Billing NDC | 42507033606 |
| Package | 177 mL in 1 BOTTLE, PLASTIC (42507-336-06) |
| Marketing Start Date | 2015-03-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 29e85927-d945-4f39-ad37-bf4776bb25d5 Details
Active ingredients (in each 20 mL)
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- headache
- sinus congestion and pressure
- sore throat
- minor aches and pains
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
- temporarily promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
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.
- for children under 12 years of age
- 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
- diabetes
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- redness or swelling is present
- nervousness, dizziness or sleeplessness occur
- new symptoms occur
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition.
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.
Directions
- do not take more than directed (see overdose warning)
- do not take more than 6 doses in any 24-hour period
- measue only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter
- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
Other information
Inactive ingredients
Principal Display Panel
*Compare to the active ingredients of Mucinex® Fast-Max® Cold, Flu & Sore Throat
Maximum Strength
Mucus Relief
Cold, Flu & Sore Throat
Acetaminophen-Pain reliever/fever reducer
Dextromethorphan HBr-Cough suppressant
Guaiffenesin-Expectorant
Phenylephrine HCl-Nasal Decongestant
- relieves headache and fever
- controls cough
- relieves nasal and chest congestion
- thins and loosens mucus
- ages 12+
DISTRIBUTED BY HY-VEE, INC.
WEST DES MOINES, IA 50266
CALL 1-800-289-8343
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex® Fast-Max® Maximum Strength Cold Flu & Sore Throat.
INGREDIENTS AND APPEARANCE
| MUCUS RELIEF COLD FLU AND SORE THROAT
MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid |
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| Labeler - Hy-Vee (006925671) |