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NDC 41163-0737-06 Maximum Strength Mucus Relief Cold,Flu and Sore Throat 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL Details
Maximum Strength Mucus Relief Cold,Flu and Sore Throat 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
Maximum Strength Mucus Relief Cold,Flu and Sore Throat is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by SUPERVALU INC. 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: 41163-0737-06Last 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: 41163-0737-06Last 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: 41163-0737-06Last 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: 41163-0737-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 41163-0737 |
|---|---|
| Product ID | 41163-737_be535a56-1b95-424e-8197-566976ef2efa |
| 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 | Maximum Strength Mucus Relief Cold,Flu and Sore Throat |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, 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 | SUPERVALU INC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [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 41163-0737-06 (41163073706)
| NDC Package Code | 41163-737-06 |
|---|---|
| Billing NDC | 41163073706 |
| Package | 180 mL in 1 BOTTLE, PLASTIC (41163-737-06) |
| Marketing Start Date | 2017-09-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL be535a56-1b95-424e-8197-566976ef2efa Details
SPL UNCLASSIFIED SECTION
Uses
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- temporarily relieves these common cold and flu symptoms:
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- nasal congestion
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- sinus congestion and pressure
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- cough due to minor throat and bronchial irritation
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- minor aches and pains
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- sore throat
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- headache
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- temporarily reduces fever
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- temporarily promotes nasal and/or sinus drainage
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
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 daily 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
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- 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
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- liver disease
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- heart disease
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- high blood pressure
- •
- thyroid disease
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- diabetes
- •
- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occur
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- 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
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- new symptoms occur
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- cough comes back, or occurs with rash, or persistent headache.
These could be signs of a serious condition.
Overdose warning
Directions
- •
- do not take more than directed (see Overdose Warning))
- •
- do not take more than 6 doses in any 24-hour period
- •
- measure only with dosing cup provided
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- do not use dosing cup with other products
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- dose as follows or as directed by a doctor
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- mL= milliliter
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- 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
EQUALINE®
NDC 41163-737-06
Compare to Mucinex® Fast-Max™ Cold, Flu & Sore Throat active ingredients*
maximum strength‡
mucus relief
cold, flu & sore throat
acetaminophen (pain reliever-fever reducer)
dextromethorphan HBr (cough suppressant)
guaifenesin (expectorant)
phenylephrine HCl ( nasal decongestant)
- •
- relieves headache & fever
- •
- control cough
- •
- relieves nasal & chest congestion
- •
- thins & loosens mucus
For ages 12+
6FL OZ (180mL)
Tamper evident: do not use if printed seal under cap is broken or missing.
‡Maximum Strength per 4 hour dose.
DISTRIBUTED BY
SUPERVALU INC,
EDEN PRAIRIE,
MN 55344 USA
877-932-7948
Supervaluprivatebrands.com
*This product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength Mucinex® Fast-Max™ Cold, Flu & Sore Throat.
INGREDIENTS AND APPEARANCE
| MAXIMUM STRENGTH MUCUS RELIEF COLD,FLU AND SORE THROAT
acetaminophen, dextromethorphan hydrobromide, guaifenesin ,phenylephrine hcl liquid |
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| Labeler - SUPERVALU INC (006961411) |